Clinical trial NCT01751906: ABSORB III Randomized Controlled Trial (RCT)
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
Bioresorbable
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: 2012-12-18
Enrollment: 2008
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: The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).

The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial designs are related, ABSORB IV is the continuation of ABSORB III and 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.

Detailed description: ABSORB III RCT:

A. Primary Objective: The pivotal trial to support the US pre-market approval (PMA) of Absorb BVS. ABSORB III will evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

B. Powered Secondary Objectives:

1. Lead-In Phase Objective: To evaluate the applicability and transferability of the didactic Absorb BVS physician training plan to US clinical practice.

   The lead-in phase is a non-randomized, single-arm, open label group of up to 50 subjects treated with Absorb BVS at up to 35 US sites. The Lead-In phase will enroll/register subjects prior to the randomization phase of ABSORB III.

   The Lead-In Phase allows the treatment of up to two de novo native coronary artery lesions in different epicardial vessels with reference vessel diameter (RVD) ≥ 2.75 mm to ≤ 3.25 mm and lesion lengths ≥ 8 to ≤ 14 mm.
2. Imaging Cohort Objective: To evaluate long-term vascular function and patency of the Absorb BVS treated segments compared to XIENCE treated segments in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

The imaging cohort-phase is a prospective, randomized (2:1 Absorb BVS to XIENCE), single-blind, multi-center trial, registering approximately 200 subjects. This includes 150 subjects for the angiographic/intravascular ultrasound (IVUS) endpoints analysis and approximately 50 subjects for optical coherence tomography (OCT) endpoints analysis. The 200 subjects are separate from the 2000 subjects included in the primary analysis. Data from two powered secondary endpoints from this cohort will support label claims of superiority of Absorb BVS as compared to XIENCE specific to vasomotion and late lumen enlargement.

All other subjects in ABSORB III unless specified will receive treatment of up to two de novo native coronary artery lesions in different epicardial vessels with RVD ≥ 2.5 mm to ≤ 3.75 mm and lesion lengths ≤ 24 mm.

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., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI. Subjects with stable angina or silent ischemia and \< 70% diameter stenosis must have objectives sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG). In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia.
4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
5. 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.
6. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
7. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 1 year following the index procedure.

Angiographic Inclusion Criteria:

1. One or two de novo target lesions:

   1. If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.
   2. If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
   3. The definition of epicardial vessels means the LAD, LCX and RCA and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.
2. 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 TIMI flow of ≥ 1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve, stress test), unstable angina or post-infarct angina.

   1. Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.
   2. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.
   3. For Lead-In subjects with 3.0x18 mm Absorb BVS: lesions (s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.75 mm and ≤ 3.25 mm. The lesion length by visual estimation is ≥ 8 mm and ≤ 14 mm.

General Exclusion Criteria:

1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist 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 aspirin; or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
4. Subject had an acute myocardial infarction (AMI; STEMI or NSTEMI) within 72 hours of the index procedure and both CK and CK-MB have not returned to within normal limits at the time of index procedure; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure.
5. Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
6. Subject has a cardiac arrhythmia as 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.
7. 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 ACS, LVEF must be assessed during the index hospitalization (which may include during the index procedure by contrast left ventriculography) but prior to randomization in order to confirm the subject's eligibility.
8. 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 24 hours and 30 days before the index procedure if successful and uncomplicated.
9. Subject requires future staged PCI either in target or non-target vessels or subject requires future peripheral interventions \< 30 days after the index procedure
10. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
11. At the time of screening, the subject has a malignancy that is not in remission.
12. 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.
13. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
14. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or any other agent for any reason).
15. Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3.
16. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
17. Subject has renal insufficiency as defined as an estimated GFR \< 30 ml/min/1.73m2 or dialysis at the time of screening.
18. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months.
19. 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.).
20. 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.
21. Subject has life expectancy \< 5 years for any non-cardiac cause or cardiac cause.
22. 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.
23. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
24. 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 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. Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes:

   1. Residual %DS is a maximum \< 40% (per visual estimation), ≤ 20% is strongly recommended.
   2. TIMI Grade-3 flow (per visual estimation).
   3. No angiographic complications (e.g. distal embolization, side branch closure).
   4. No dissections NHLBI grade D-F.
   5. No chest pain lasting \> 5 minutes.
   6. No ST depression or elevation lasting \> 5 minutes.
2. Lesion is located in left main.
3. Aorto-ostial RCA lesion (within 3 mm of the ostium).
4. Lesion located within 3 mm of the origin of the LAD or 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 IVUS used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
7. Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.
8. Lesion or vessel involves a myocardial bridge.
9. Vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS or XIENCE would need to cross the stent to reach the target lesion.
10. Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.
11. Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.

Primary outcomes:
measure: Number of Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants With Powered Secondary Endpoint: Angina
timeFrame: 1 year
measure: Number of Participants With Powered Secondary Endpoint: All Revascularization
timeFrame: 1 year
measure: Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 1 year
measure: Acute Success- Device Success (Lesion Level Analysis)
timeFrame: On day 0 (the day of procedure)
measure: Acute Success: Procedural Success (Subject Level Analysis)
timeFrame: On day 0 (the day of procedure)
measure: Number of Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: 0 to 5 years
measure: Number of Participants With All Myocardial Infarction (MI)
timeFrame: 0 to 5 years
measure: Number of Participants With All Target Lesion Revascularization (TLR)
timeFrame: 0 to 5 years
measure: Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)
timeFrame: 0 to 5 years
measure: Number of Participants With All Revascularization
timeFrame: 0 to 5 years
measure: Number of Death/All MI
timeFrame: 0 to 5 years
measure: Number of Cardiac Death/All MI
timeFrame: 0 to 5 years
measure: Number of Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 0 to 5 years
measure: Number of Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
timeFrame: 0 to 5 years
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 0 to 5 years
measure: Number of Death/All MI/All Revascularization (DMR)
timeFrame: 0 to 5 years
measure: Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition)
timeFrame: ≤ 1 Day
measure: Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition)
timeFrame: 0 to 30 Days
measure: Number of Participants With Subacute Stent/Scaffold Thrombosis
timeFrame: >1 to 30 Days
measure: Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)
timeFrame: 31 to 365 Days
measure: Number of Participants With Very Late Stent /Scaffold Thrombosis (Per ARC Definition)
timeFrame: 366 to 393 Days
measure: Number of Participants With Cumulative Stent/Scaffold Thrombosis
timeFrame: 0 to 1853 Days
measure: Pre-Procedure Minimum Lumen Diameter (MLD)
timeFrame: < or = 1 day
measure: Pre-Procedure Percent Diameter Stenosis (%DS)
timeFrame: < or = 1 day
measure: Post-Procedure In-Segment Minimum Lumen Diameter (MLD)
timeFrame: ≤ 7 days post index procedure
measure: Post-Procedure In-Segment Percent Diameter Stenosis (%DS)
timeFrame: ≤ 7 days post index procedure
measure: Post-Procedure In-Device Minimum Lumen Diameter (MLD)
timeFrame: ≤ 7 days post index procedure
measure: Post-Procedure In-Device Percent Diameter Stenosis (%DS)
timeFrame: ≤ 7 days post index procedure
measure: Post-Procedure In-Device Acute Gain
timeFrame: ≤ 7 days post index procedure
measure: Powered Imaging Cohort Secondary Endpoint: The Instent/Scaffold Mean Lumen Area Change, From Post Procedure to 3 Years by Intravascular Ultrasound (IVUS)
timeFrame: From Post procedure to 3 Years
measure: Optical Coherence Tomography (OCT) Endpoint: Mean Neointimal Area (NIA)
timeFrame: 3 Years
measure: Optical Coherence Tomography (OCT) Endpoint: Mean Device Area, Adluminal
timeFrame: 3 Years
measure: Optical Coherence Tomography (OCT) Endpoint: Mean Lumen Area
timeFrame: 3 Years
measure: Optical Coherence Tomography (OCT) Endpoint: Minimal Lumen Area
timeFrame: 3 Years
measure: Optical Coherence Tomography (OCT) Endpoint: Percentage of Malapposition Struts
timeFrame: 3 Years
Other outcomes:
measure: Patient Reported Outcomes (PRO): Overall Health Status
timeFrame: Baseline
measure: Patient Reported Outcomes (PRO): Overall Health Status
timeFrame: 1 month
measure: Patient Reported Outcomes (PRO): Overall Health Status
timeFrame: 12 months
measure: Patient Reported Outcomes (PRO): Anxiety
timeFrame: Baseline
measure: Patient Reported Outcomes (PRO): Anxiety
timeFrame: 1 month
measure: Patient Reported Outcomes (PRO): Anxiety
timeFrame: 12 months
measure: Patient Reported Outcomes (PRO): Disease-Specific Quality of Life
timeFrame: Baseline
measure: Patient Reported Outcomes (PRO): Disease-Specific Quality of Life
timeFrame: 1 month
measure: Patient Reported Outcomes (PRO): Disease-Specific Quality of Life
timeFrame: 12 months
measure: Patient Reported Outcomes (PRO): Dyspnea Severity
timeFrame: Baseline
measure: Patient Reported Outcomes (PRO): Dyspnea Severity
timeFrame: 1 month
measure: Patient Reported Outcomes (PRO): Dyspnea Severity
timeFrame: 12 months
measure: Landmark Analysis on TLF and Components
timeFrame: 3-4 years
measure: Landmark Analysis on TLF and Components
timeFrame: 3-5 years
measure: Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
timeFrame: 3-4 years
measure: Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
timeFrame: 3-5 years
Locations:
city: Birmingham
country: United States
facility: Baptist Medical Center Princeton
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama Hospital
state: Alabama
city: Fairhope
country: United States
facility: Thomas Hospital
state: Alabama
city: Montgomery
country: United States
facility: Baptist Medical Center South
state: Alabama
city: Gilbert
country: United States
facility: Chandler Regional Medical Center
state: Arizona
city: Mesa
country: United States
facility: Banner Heart Hospital
state: Arizona
city: Phoenix
country: United States
facility: Banner Good Samaritan 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 Medical Center - Concord Campus
state: California
city: Fremont
country: United States
facility: Washington Hospital
state: California
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Modesto
country: United States
facility: Sutter Central Valley Hospitals dba Memorial Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage 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: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Colorado Springs
country: United States
facility: UCH-Memorial Health Systems
state: Colorado
city: Fort Collins
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: Stamford
country: United States
facility: St. Vincent's Medical Center
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Brandon
country: United States
facility: Brandon Regional Hospital
state: Florida
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center - Downtown
state: Florida
city: Jacksonville
country: United States
facility: University of Florida UF Health
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Ocala
country: United States
facility: MediQuest Research Group Inc at Munroe Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Gardens Medical Center
state: Florida
city: Panama City
country: United States
facility: Bay County Health Systems
state: Florida
city: Pensacola
country: United States
facility: Baptist Hospital
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: Tampa
country: United States
facility: Florida Hospital Pepin Heart Institute
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Saint Joseph's Hospital of Atlanta
state: Georgia
city: Augusta
country: United States
facility: University Hospital
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Marietta
country: United States
facility: Wellstar Kennestone 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: Peoria
country: United States
facility: Saint Francis Medical Center
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Elkhart
country: United States
facility: Elkhart General Healthcare
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: West Des Moines
country: United States
facility: Mercy Medical
state: Iowa
city: Kansas City
country: United States
facility: The University of Kansas Hospital and Medical Center
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Hyattsville
country: United States
facility: MedStar Washington Hospital Center
state: Maryland
city: Hyattsville
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Salisbury
country: United States
facility: Peninsula Regional Medical Center
state: Maryland
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Brighton
country: United States
facility: St. Elizabeth's Medical Center of Boston
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Bay City
country: United States
facility: Bay Regional Medical Center
state: Michigan
city: Dearborn
country: United States
facility: Oakwood Hospital and Medical Center
state: Michigan
city: Detroit
country: United States
facility: Harper University Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital & Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Lansing
country: United States
facility: Sparrow Hospital
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: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Ypsilanti
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Medical Center
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center Cardiology Associates Research, LLC
state: Mississippi
city: Columbia
country: United States
facility: Boone Hospital Center
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. Anthony's Medical Center
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 Hospital
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Haddon Heights
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Haddon Heights
country: United States
facility: Our Lady of Lourdes Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Paterson
country: United States
facility: St. Joseph's Regional Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Hospital
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Liverpool
country: United States
facility: St. Joseph's Hospital Health Center
state: New York
city: Manhasset
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
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: New York
country: United States
facility: New York Presbyterian Hospital-Cornell University
state: New York
city: New York
country: United States
facility: Lennox Hill Hospital,
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Rochester
country: United States
facility: Strong Memorial Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Rex Hospital
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University Hospital
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Tri-Health Good Samaritan Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
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: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Elyria
country: United States
facility: EMH Healthcare
state: Ohio
city: Fairview Park
country: United States
facility: Cleveland Cln Fairview Hospital
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Toledo
country: United States
facility: Mercy St. Vincent's Medical Center
state: Ohio
city: Zanesville
country: United States
facility: Genesis-Good Samaritan Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Tulsa
country: United States
facility: Hillcrest Medical Center
state: Oklahoma
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Springfield
country: United States
facility: PeaceHealth Sacred Heart Medical Center
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
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: Erie
country: United States
facility: UPMC Hamot
state: Pennsylvania
city: Langhorne
country: United States
facility: St. Mary Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside Hospital
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health at Harrisburg Hospital
state: Pennsylvania
city: Wyomissing
country: United States
facility: St. Joseph Medical Center
state: Pennsylvania
city: York
country: United States
facility: York Hospital
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
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Sisters of Charity Providence Hospital
state: South Carolina
city: Greenville
country: United States
facility: Greenville Memorial Hospital of the Greenville Health System
state: South Carolina
city: Greenville
country: United States
facility: St. Francis Health System
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center
state: South Dakota
city: Chattanooga
country: United States
facility: Memorial Hospital
state: Tennessee
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical Center
state: Tennessee
city: Knoxville
country: United States
facility: Turkey Creek 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 Austin
state: Texas
city: Dallas
country: United States
facility: Baylor Jack and Jane Hamilton Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: San Antonio
country: United States
facility: Methodist Texsan Hospital
state: Texas
city: Tyler
country: United States
facility: East Texas Medical Center
state: Texas
city: Tyler
country: United States
facility: Trinity Mother Frances Hospital Regional Healthcare Center
state: Texas
city: Murray
country: United States
facility: InterMountain Medical Center
state: Utah
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Fredericksburg
country: United States
facility: Mary Washington Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Bellingham
country: United States
facility: St. Joseph Hospital
state: Washington
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
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
Study officials:
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
affiliation: Columbia University Medical Center, New York, NY
name: Gregg W Stone, MD
role: STUDY_CHAIR
affiliation: Abbott Medical Devices
name: Jennifer McMeans Jones
role: STUDY_DIRECTOR
References:
citation: Nishi T, Okada K, Kitahara H, Kameda R, Ikutomi M, Imura S, Hollak MB, Yock PG, Popma JJ, Kusano H, Cheong WF, Sudhir K, Fitzgerald PJ, Ellis SG, Kereiakes DJ, Stone GW, Honda Y, Kimura T; ABSORB III and ABSORB Japan Investigators. Intravascular ultrasound predictors of long-term outcomes following ABSORB bioresorbable scaffold implantation: A pooled analysis of the ABSORB III and ABSORB Japan trials. J Cardiol. 2021 Sep;78(3):224-229. doi: 10.1016/j.jjcc.2021.03.005. Epub 2021 Apr 21.
citation: Stone GW, Kimura T, Gao R, Kereiakes DJ, Ellis SG, Onuma Y, Chevalier B, Simonton C, Dressler O, Crowley A, Ali ZA, Serruys PW. Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study. JAMA Cardiol. 2019 Dec 1;4(12):1261-1269. doi: 10.1001/jamacardio.2019.4101.
citation: Kereiakes DJ, Ellis SG, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, Tan SH, Ediebah DE, Simonton C, Stone GW; ABSORB III Investigators. Clinical Outcomes Before and After Complete Everolimus-Eluting Bioresorbable Scaffold Resorption: Five-Year Follow-Up From the ABSORB III Trial. Circulation. 2019 Dec 3;140(23):1895-1903. doi: 10.1161/CIRCULATIONAHA.119.042584. Epub 2019 Sep 25.
citation: Kereiakes DJ, Ellis SG, Metzger C, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, McGreevy R, Zhang Z, Simonton C, Stone GW; ABSORB III Investigators. 3-Year Clinical Outcomes With Everolimus-Eluting Bioresorbable Coronary Scaffolds: The ABSORB III Trial. J Am Coll Cardiol. 2017 Dec 12;70(23):2852-2862. doi: 10.1016/j.jacc.2017.10.010. Epub 2017 Oct 31.
citation: Ali ZA, Gao R, Kimura T, Onuma Y, Kereiakes DJ, Ellis SG, Chevalier B, Vu MT, Zhang Z, Simonton CA, Serruys PW, Stone GW. Three-Year Outcomes With the Absorb Bioresorbable Scaffold: Individual-Patient-Data Meta-Analysis From the ABSORB Randomized Trials. Circulation. 2018 Jan 30;137(5):464-479. doi: 10.1161/CIRCULATIONAHA.117.031843. Epub 2017 Oct 31.
citation: Baron SJ, Lei Y, Chinnakondepalli K, Vilain K, Magnuson EA, Kereiakes DJ, Ellis SG, Stone GW, Cohen DJ; ABSORB III Investigators. Economic Outcomes of Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: 1-Year Results From the ABSORB III Trial. JACC Cardiovasc Interv. 2017 Apr 24;10(8):774-782. doi: 10.1016/j.jcin.2017.01.022.
citation: Stone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016 Mar 26;387(10025):1277-89. doi: 10.1016/S0140-6736(15)01039-9. Epub 2016 Jan 27.
citation: Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, McGreevy R, Zhang Z, Simonton C, Stone GW; ABSORB III Investigators. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med. 2015 Nov 12;373(20):1905-15. doi: 10.1056/NEJMoa1509038. Epub 2015 Oct 12.
citation: Kereiakes DJ, Ellis SG, Popma JJ, Fitzgerald PJ, Samady H, Jones-McMeans J, Zhang Z, Cheong WF, Su X, Ben-Yehuda O, Stone GW. Evaluation of a fully bioresorbable vascular scaffold in patients with coronary artery disease: design of and rationale for the ABSORB III randomized trial. Am Heart J. 2015 Oct;170(4):641-651.e3. doi: 10.1016/j.ahj.2015.07.013. Epub 2015 Jul 26.