Clinical trial NCT02173379: Absorb IV Randomized Controlled Trial
Official title: A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Coronary Artery Stenosis
Coronary Disease
Coronary Stenosis
Keywords: Absorb™ BVS
Angioplasty
Bioabsorbable
BVS
Coronary Artery Disease
Coronary Artery Endothelial Responsiveness
Coronary artery restenosis
Coronary artery stenosis
Coronary scaffold
Coronary Stent
Drug eluting stents
Everolimus
Myocardial ischemia
Stent thrombosis
Stents
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-06-25
Enrollment: 2604
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States. ABSORB IV is a continuation of ABSORB III (NCT01751906) trial which are maintained under one protocol because both trial designs are related. The data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.

The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the safety and effectiveness as well as the potential short and long-term benefits of Abbott Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System (once commercially available), as compared to the commercially approved, control stent XIENCE.

Detailed description: ABSORB IV:

A. Primary Objective:

* To evaluate 30-day clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.
* To evaluate long-term clinical outcomes of Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three denovo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.

B. Secondary Objectives:

* To evaluate 1-year clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.
* To evaluate the incidence of angina occurring within 1 year, with treatment of Absorb BVS compared to XIENCE.

The enrollment of the 2610 subjects in ABSORB IV will start after enrollment completion of the 2000 primary analysis subjects in ABSORB III. All registered subjects will have clinical follow-up at 30, 90, 180, 270 days and 1, 2, 3, 4 and 5 years.

Note: All registered subjects in ABSORB IV will be followed up to 5 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

In addition, all 2610 subjects in ABSORB IV will complete patient-reported outcome (PRO) self-administered questionnaires at baseline, 30 days,180 days, 1 year, 3 years and 5 years.

Eligibility criteria: General Inclusion Criteria:

1. Subject must be at least 18 years of age.
2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
3. Subject must have evidence of myocardial ischemia (e.g., silent ischemia, stable or unstable angina, non-ST-segment elevation MI (NSTEMI), OR recent ST-segment elevation MI (STEMI). Patients with stable coronary syndromes can be enrolled any time after symptom onset if eligibility criteria are otherwise met. Patients with acute coronary syndrome can be enrolled under the following conditions:

   1. Unstable angina or NSTEMI within 2 weeks of the index procedure.
   2. STEMI \> 72 hours ≤ 2 weeks prior to the index procedure.

   Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring \> 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.
4. Subjects must be suitable for PCI. Subjects with stable angina or silent ischemia and \< 70% diameter stenosis must have objective signs of ischemia as determined by one of the following: abnormal stress echocardiogram, nuclear scan, electrocardiogram (ECG), positron emission tomography (PET), magnetic resonance imaging (MRI), and/or fractional flow reserve (FFR).

   (Note: subject with silent ischemia must have a prior history of typical angina, angina-equivalent symptoms, or atypical angina within the past year to be included in the trial.)
5. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
6. Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard.
7. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for at least 1 year following the index procedure.
8. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 5 years following the index procedure.

Angiographic Inclusion Criteria:

Treatment of up to three de novo lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel. If only a single lesion is to be treated, it must be a target lesion. Up to one non-target lesion can be treated. Non-target lesion treatment can occur only in a non-target vessel.

If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion for lesion (and stent) length determination and must be treated with a single study device.

1. Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed %DS of ≥50% and \< 100%, with a thrombolysis in myocardial infarction (TIMI) flow of ≥ 1, and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve ≤0.80 AND/OR a positive stress test), or presentation with an acute coronary syndrome (unstable angina or NSTEMI within 2 weeks of index procedure, or STEMI \>72 hours but ≤ 2 weeks prior to the index procedure).

1. Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.
2. Target lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.

Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring \> 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.

Note: To exclude enrollment of excessively small vessels, if the operator believes that based on visual angiographic assessments, the distal reference vessel diameter is ≤ 2.75 mm such that the plan is to implant a 2.5 mm device (stent or scaffold) in a target lesion, it is strongly recommended that either on-line QCA or intravascular imaging (ultrasound or optical coherence tomography) is used and demonstrates that the measured distal RVD for this target lesion is ≥ 2.50 mm (by at least one of these imaging modalities). This measurement may be performed before or after pre-dilatation, but before randomization. If the distal RVD measures \<2.5 mm, that lesion IS NOT ELIGIBLE for randomization. Such a lesion may be treated as a non-target lesion.

General Exclusion Criteria:

1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or a P2Y12 receptor inhibitor is planned within 12 months after the procedure.
2. Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
3. Subject has known allergic reaction, hypersensitivity or contraindication to any of the following: aspirin; or clopidogrel and prasugrel and ticagrelor; or heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
4. Subject had an acute STEMI (appropriate clinical syndrome with ≥1 mm of ST-segment elevation in ≥2 contiguous leads) within 72 hours of the index procedure.
5. Subject has a cardiac arrhythmia identified at the time of screening for which at least one of the following criteria is met:

   1. Subject requires coumadin or any other agent for chronic oral anticoagulation.
   2. Subject is likely to become hemodynamically unstable due to their arrhythmia.
   3. Subject has poor survival prognosis due to their arrhythmia.
6. Subject has a left ventricular ejection fraction (LVEF) \< 30% assessed by any quantitative method, including but not limited to echocardiography, MRI, multiple-gated acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc. LVEF may be obtained within 6 months prior to the procedure for subjects with stable CAD. For subjects presenting with acute coronary syndrome (ACS), LVEF must be assessed within 1 week of the index procedure and after ACS presentation, which may include contrast left ventriculography during the index procedure but prior to randomization in order to confirm the subject's eligibility.
7. Subject has undergone prior PCI within the target vessel during the last 12 months. Prior PCI within the non-target vessel or any peripheral intervention is acceptable if performed anytime \>30 days before the index procedure, or between a minimum of 24 hours and 30 days before the index procedure if successful and uncomplicated.
8. Subject requires future staged PCI of any lesion other than a target lesion identified at the time of index procedure; or subject requires future peripheral vascular interventions \< 30 days after the index procedure.
9. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
10. At the time of screening, the subject has a malignancy that is not in remission.
11. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
12. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
13. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban, edoxaban or any other related agent for any reason).
14. Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3.
15. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
16. Subject has renal insufficiency as defined as an estimated glomerular filtration rate (GFR) \< 30 ml/min/1.73m2 or dialysis at the time of screening.
17. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastrointestinal or significant urinary bleed within the past six months.
18. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g. aneurysm, arteriovenous malformation, etc.).
19. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used.
20. Subject has a life expectancy \<5 years for any non-cardiac or cardiac cause.
21. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of Patient Reported Outcome instruments.
22. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
23. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with a mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria:

All exclusion criteria apply to the target lesion(s) or target vessel(s).

1. Unsuccessful pre-dilatation, defined as the presence of one or more of the following (note: successful pre-dilatation of at least one target lesion is required prior to randomization):

   1. Residual %diameter stenosis (DS) after pre-dilatation is ≥ 40% (per visual estimation). Note: achieving a %DS ≤ 20% prior to randomization is strongly recommended.
   2. TIMI flow grade \<3 (per visual estimation).
   3. Any angiographic complication (e.g. distal embolization, side branch closure).
   4. Any dissection NHLBI grade D-F.
   5. Any chest pain lasting \> 5 minutes.
   6. Any ST-segment depression or elevation lasting \> 5 minutes.
2. Lesion is located in left main or there is a ≥30% diameter stenosis in the left main (unless the left main lesion is a protected left main (i.e. a patent bypass graft to the LAD and/or LCX arteries is present), and there is no intention to treat the protected left main lesion).
3. Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).
4. Lesion located within 3 mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX).
5. Lesion involving a bifurcation with a:

   1. side branch ≥ 2 mm in diameter, or
   2. side branch with either an ostial or non-ostial lesion with diameter stenosis \>50%, or
   3. side branch requiring dilatation
6. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE stent:

   1. Extreme angulation (≥ 90°) proximal to or within the target lesion.
   2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
   3. Moderate or heavy calcification proximal to or within the target lesion. If intravascular ultrasound (IVUS) used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
7. Lesion or vessel involves a myocardial bridge.
8. Vessel has been previously treated with a stent and the target lesion is within 5 mm proximal or distal to a previously stented lesion.
9. Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.

Primary outcomes:
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 30 days
Secondary outcomes:
measure: TLF at 1-year, Non-inferiority Against the Control
timeFrame: 1 year
measure: Angina at 1-year, Non-inferiority Against the Control
timeFrame: 1 year
measure: Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis)
timeFrame: In-hospital (≤ 7days)
measure: Number of Participants With Acute Success- Procedural Success (Subject Level Analysis)
timeFrame: In-hospital (≤ 7days)
measure: Number of Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: In-hospital (≤ 7 days post index procedure)
measure: Number of Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: 30 days
measure: Number of Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: 90 days
measure: Number of Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: 180 days
measure: Number of Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: 270 days
measure: Number of Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: 1 year
measure: Number of Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: 2 years
measure: Number of Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: 3 years
measure: Number of Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: 4 years
measure: Number of Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: 5 years
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: In-hospital (≤ 7 days post index procedure)
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: 30 days
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: 90 days
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: 180 days
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: 270 days
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: 1 year
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: 2 years
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: 3 years
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: 4 years
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: 5 years
measure: Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
timeFrame: In-hospital (≤ 7 days post index procedure)
measure: Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
timeFrame: 30 days
measure: Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
timeFrame: 90 days
measure: Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
timeFrame: 180 days
measure: Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
timeFrame: 270 days
measure: Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
timeFrame: 1 year
measure: Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
timeFrame: 2 year
measure: Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
timeFrame: 3 years
measure: Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
timeFrame: 4 years
measure: Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
timeFrame: 5 years
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: In-hospital (≤ 7 days post index procedure)
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 30 days
measure: Number of Participants withTarget Lesion Revascularization (TLR)
timeFrame: 90 days
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 180 days
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 270 days
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 1 year
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 2 years
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 3 years
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 4 years
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 5 years
measure: Number of Participants With Ischemia Driven TLR (ID-TLR)
timeFrame: In-hospital (≤ 7 days post index procedure)
measure: Number of Participants With Ischemia Driven TLR (ID-TLR)
timeFrame: 30 days
measure: Number of Participants With Ischemia Driven TLR (ID-TLR)
timeFrame: 90 days
measure: Number of Participants With Ischemia Driven TLR (ID-TLR)
timeFrame: 180 days
measure: Number of Participants With Ischemia Driven TLR (ID-TLR)
timeFrame: 270 days
measure: Number of Participants With Ischemia Driven TLR (ID-TLR)
timeFrame: 1 year
measure: Number of Participants With Ischemia Driven TLR (ID-TLR)
timeFrame: 2 years
measure: Number of Participants With Ischemia Driven TLR (ID-TLR)
timeFrame: 3 years
measure: Number of Participants With Ischemia Driven TLR (ID-TLR)
timeFrame: 4 years
measure: Number of Participants With Ischemia Driven TLR (ID-TLR)
timeFrame: 5 years
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: In-hospital (≤ 7 days post index procedure)
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: 30 days
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: 90 days
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: 180 days
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: 270 days
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: 1 year
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: 2 years
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: 3 years
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: 4 years
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: 5 years
measure: Number of Participants With ID-TVR Excluding TLR
timeFrame: In-hospital (≤ 7 days post index procedure)
measure: Number of Participants With ID-TVR Excluding TLR
timeFrame: 30 days
measure: Number of Participants With ID-TVR Excluding TLR
timeFrame: 90 days
measure: Number of Participants With ID-TVR Excluding TLR
timeFrame: 180 days
measure: Number of Participants With ID-TVR Excluding TLR
timeFrame: 270 days
measure: Number of Participants With ID-TVR Excluding TLR
timeFrame: 1 year
measure: Number of Participants With ID-TVR Excluding TLR
timeFrame: 2 years
measure: Number of Participants With ID-TVR Excluding TLR
timeFrame: 3 years
measure: Number of Participants With ID-TVR Excluding TLR
timeFrame: 4 years
measure: Number of Participants With ID-TVR Excluding TLR
timeFrame: 5 years
measure: Number of Participants With All Coronary Revascularization
timeFrame: In-hospital (≤ 7 days post index procedure)
measure: Number of Participants With All Coronary Revascularization
timeFrame: 30 days
measure: Number of Participants With All Coronary Revascularization
timeFrame: 90 days
measure: Number of Participants With All Coronary Revascularization
timeFrame: 180 days
measure: Number of Participants With All Coronary Revascularization
timeFrame: 270 days
measure: Number of Participants With All Coronary Revascularization
timeFrame: 1 year
measure: Number of Participants With All Coronary Revascularization
timeFrame: 2 years
measure: Number of Participants With All Coronary Revascularization
timeFrame: 3 years
measure: Number of Participants With All Coronary Revascularization
timeFrame: 4 years
measure: Number of Participants With All Coronary Revascularization
timeFrame: 5 years
measure: Number of Participants Experienced All Death/All MI
timeFrame: In-hospital (≤ 7 days post index procedure)
measure: Number of Participants Experienced All Death/All MI
timeFrame: 30 days
measure: Number of Participants Experienced All Death/All MI
timeFrame: 90 days
measure: Number of Participants Experienced All Death/All MI
timeFrame: 180 days
measure: Number of Participants Experienced All Death/All MI
timeFrame: 270 days
measure: Number of Participants Experienced All Death/All MI
timeFrame: 1 year
measure: Number of Participants Experienced All Death/All MI
timeFrame: 2 years
measure: Number of Participants Experienced All Death/All MI
timeFrame: 3 years
measure: Number of Participants Experienced All Death/All MI
timeFrame: 4 years
measure: Number of Participants Experienced All Death/All MI
timeFrame: 5 years
measure: Number of Participants Experienced Cardiac Death/All MI
timeFrame: In-hospital (≤ 7 days post index procedure)
measure: Number of Participants Experienced Cardiac Death/All MI
timeFrame: 30 days
measure: Number of Participants Experienced Cardiac Death/All MI
timeFrame: 90 days
measure: Number of Participants Experienced Cardiac Death/All MI
timeFrame: 180 days
measure: Number of Participants Experienced Cardiac Death/All MI
timeFrame: 270 days
measure: Number of Participants Experienced Cardiac Death/All MI
timeFrame: 1 year
measure: Number of Participants Experienced Cardiac Death/All MI
timeFrame: 2 years
measure: Number of Participants Experienced Cardiac Death/All MI
timeFrame: 3 years
measure: Number of Participants Experienced Cardiac Death/All MI
timeFrame: 4 years
measure: Number of Participants Experienced Cardiac Death/All MI
timeFrame: 5 years
measure: Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: In-hospital (≤ 7 days post index procedure)
measure: Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 30 days
measure: Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 90 days
measure: Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 180 days
measure: Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 270 days
measure: Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 1 year
measure: Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 2 years
measure: Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 3 years
measure: Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 4 years
measure: Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 5 years
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
timeFrame: In-hospital (≤ 7 days post index procedure)
measure: Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE)
timeFrame: 30 days
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
timeFrame: 90 days
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
timeFrame: 180 days
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
timeFrame: 270 days
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
timeFrame: 1 year
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
timeFrame: 2 years
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
timeFrame: 3 years
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
timeFrame: 4 years
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
timeFrame: 5 years
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF)
timeFrame: In-hospital (≤ 7 days post index procedure)
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
timeFrame: 30 days
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
timeFrame: 90 days
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
timeFrame: 180 days
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
timeFrame: 270 days
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
timeFrame: 1 year
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
timeFrame: 2 years
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
timeFrame: 3 years
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
timeFrame: 4 years
measure: Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
timeFrame: 5 years
measure: Number of Participants Experienced Death/All MI/All Revascularization (DMR)
timeFrame: In-hospital (≤ 7 days post index procedure)
measure: Number of Participants Experienced Death/All MI/All Revascularization (DMR)
timeFrame: 30 days
measure: Number of Participants Experienced Death/All MI/All Revascularization (DMR)
timeFrame: 90 days
measure: Number of Participants Experienced Death/All MI/All Revascularization (DMR)
timeFrame: 180 days
measure: Number of Participants Experienced Death/All MI/All Revascularization (DMR)
timeFrame: 270 days
measure: Number of Participants Experienced Death/All MI/All Revascularization (DMR)
timeFrame: 1 year
measure: Number of Participants Experienced Death/All MI/All Revascularization (DMR)
timeFrame: 2 years
measure: Number of Participants Experienced Death/All MI/All Revascularization (DMR)
timeFrame: 3 years
measure: Number of Participants Experienced Death/All MI/All Revascularization (DMR)
timeFrame: 4 years
measure: Number of Participants Experienced Death/All MI/All Revascularization (DMR)
timeFrame: 5 years
measure: Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition)
timeFrame: 0 - 24 hours post stent implantation
measure: Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition)
timeFrame: >24 hours - 30 days post stent implantation
measure: Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)
timeFrame: 30 days - 1 year post stent implantation
measure: Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition)
timeFrame: 0 to 730 Days
measure: Number of Participants With Rehospitalization
timeFrame: 30 days
measure: Number of Participants With Rehospitalization
timeFrame: 90 days
measure: Number of Participants With Rehospitalization
timeFrame: 180 days
measure: Number of Participants With Rehospitalization
timeFrame: 270 days
measure: Number of Participants With Rehospitalization
timeFrame: 1 year
measure: Number of Participants With Rehospitalization
timeFrame: 2 years
measure: Number of Participants With Rehospitalization
timeFrame: 3 years
measure: Number of Participants With Rehospitalization
timeFrame: 4 years
measure: Number of Participants With Rehospitalization
timeFrame: 5 years
measure: Number of Participants With Repeat Coronary Arteriography
timeFrame: In-hospital (≤ 7 days post index procedure)
measure: Number of Participants With Repeat Coronary Arteriography
timeFrame: 30 days
measure: Number of Participants With Repeat Coronary Arteriography
timeFrame: 90 days
measure: Number of Participants With Repeat Coronary Arteriography
timeFrame: 180 days
measure: Number of Participants With Repeat Coronary Arteriography
timeFrame: 270 days
measure: Number of Participants With Repeat Coronary Arteriography
timeFrame: 1 year
measure: Number of Participants With Repeat Coronary Arteriography
timeFrame: 2 years
measure: Number of Participants With Repeat Coronary Arteriography
timeFrame: 3 years
measure: Number of Participants With Repeat Coronary Arteriography
timeFrame: 4 years
measure: Number of Participants With Repeat Coronary Arteriography
timeFrame: 5 years
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Chandler
country: United States
facility: Chandler Regional Medical Center
state: Arizona
city: Gilbert
country: United States
facility: Mercy Gilbert Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Concord
country: United States
facility: John Muir Health Concord
state: California
city: Fremont
country: United States
facility: Washington Hospital
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital La Jolla
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: Univ Of California Davis Med Ctr
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Torrance
country: United States
facility: Little Company Of Mary Hospital
state: California
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: UF Health Jacksonville
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Elkhart
country: United States
facility: Elkhart General Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Franciscan St Francis Health
state: Indiana
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lexington
country: United States
facility: University Of Kentucky Hospital
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Detroit
country: United States
facility: Harper University Hospital
state: Michigan
city: Detroit
country: United States
facility: St John Hospital & Medical Center
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Columbia
country: United States
facility: Boone Hospital Center/ Missouri Cardiovascular Specialists, LLP
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Springfield
country: United States
facility: Mercy Hospital Springfield
state: Missouri
city: Missoula
country: United States
facility: St. Patrick Hospital
state: Montana
city: Lincoln
country: United States
facility: Nebraska Heart Institute Heart Hosp.
state: Nebraska
city: Omaha
country: United States
facility: CHI Health Bergan Mercy
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Camden
country: United States
facility: Our Lady of Lourdes Medical Center
state: New Jersey
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Flushing
country: United States
facility: NewYork-Presbyterian/Queens
state: New York
city: New York
country: United States
facility: NYP Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Syracuse
country: United States
facility: St. Joseph's Hospital Health Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center-Northeast
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health Heart & Vascular Institute/Presbyterian Hospital
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center-Pineville
state: North Carolina
city: Raleigh
country: United States
facility: Rex Hospital, Inc.
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Toledo
country: United States
facility: Mercy St. Vincent Medical Center
state: Ohio
city: Zanesville
country: United States
facility: Genesis Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center, Inc.
state: Oklahoma
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Camp Hill
country: United States
facility: Holy Spirit Hospital
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health Hospitals
state: Pennsylvania
city: Monroeville
country: United States
facility: Forbes Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Upmc Presbyterian
state: Pennsylvania
city: Reading
country: United States
facility: St. Joseph Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Anderson
country: United States
facility: Anmed Health Medical Center
state: South Carolina
city: Columbia
country: United States
facility: Providence Hospital
state: South Carolina
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Amarillo
country: United States
facility: Northwest Texas Healthcare System
state: Texas
city: Austin
country: United States
facility: Seton Medical Center
state: Texas
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Tyler
country: United States
facility: East Texas Medical Center
state: Texas
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Everett
country: United States
facility: Providence Reg Med Ctr Everett
state: Washington
city: Northwest
country: United States
facility: Medstar Health Research Institute/ Medstar Washington Hospital Center
state: Washington
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: Hopital du Sacre-Coeur de Montreal
state: Quebec
city: Montréal
country: Canada
facility: CHUM-Hotel Dieu
state: Quebec
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-Württemberg
city: Immenstadt
country: Germany
facility: Kliniken Oberallgau gGmbH
state: Bavaria
city: Kempten-Allgau
country: Germany
facility: Klinikum Kempten, Klinikverbund Kempten-Oberallgaeu gGmbH
state: Bavaria
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg
state: Berlin
city: Giessen
country: Germany
facility: University Giessen
state: Hesse
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
state: Lower Saxony
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
state: North Rhine-Westphalia
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus
state: North Rhine-Westphalia
city: Mainz
country: Germany
facility: Johannes Gutenberg-Universitaet
state: Rhineland-Palatinate
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH - Herzzentrum
state: Schleswig-Holstein
city: Singapore
country: Singapore
facility: National Heart Centre, Singapore, Pte, Ltd.
Study officials:
affiliation: Columbia University Medical Center, New York, NY
name: Gregg W Stone, MD
role: STUDY_CHAIR
affiliation: Columbia University Medical Center, New York, NY
name: Gregg W Stone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland Clinic, Cleveland OH
name: Stephen G Ellis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Christ Hospital, Cincinnati, OH
name: Dean J Kereiakes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stone GW, Ellis SG, Gori T, Metzger DC, Stein B, Erickson M, Torzewski J, Williams J Jr, Lawson W, Broderick TM, Kabour A, Piegari G, Cavendish J, Bertolet B, Choi JW, Marx SO, Genereux P, Kereiakes DJ; ABSORB IV Investigators. Blinded outcomes and angina assessment of coronary bioresorbable scaffolds: 30-day and 1-year results from the ABSORB IV randomised trial. Lancet. 2018 Oct 27;392(10157):1530-1540. doi: 10.1016/S0140-6736(18)32283-9. Epub 2018 Sep 25.