Clinical trial NCT00856856: ABSORB Clinical Investigation, Cohort B
Official title: A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With de Novo Native Coronary Artery Lesions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Keywords: Bioabsorbable
Coronary Stent
Everolimus
Drug eluting stents
Stents
Angioplasty
Coronary artery disease (CAD)
Total coronary occlusion
Coronary artery restenosis
Stent thrombosis
Vascular disease
Myocardial ischemia
Coronary artery stenosis
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels.

Currently in development at Abbott Vascular. Not available for sale in the United States.


Eligibility criteria: General inclusion criteria

1. Patient must be at least 18 years of age.
2. Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the BVS Everolimus Eluting CSS and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
3. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
5. Patient must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, intravascular ultrasound (IVUS), Palpography (optional), optical coherence tomography (OCT) (strongly recommended), multislice computed tomography (MSCT) (optional) and coronary vasomotion (optional)
6. Patient must agree not to participate in any other clinical investigation for a period of two years following the index procedure

Angiographic Inclusion Criteria

1. Target lesion(s) must be located in a native coronary artery with visually estimated nominal vessel diameter of 3.0 mm
2. Target lesion(s) must measure ≤ 14 mm in length by visual estimation
3. Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 1
4. If two target lesions meet the inclusion criteria they must be in different major epicardial vessels left anterior descending artery (LAD) with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches
5. If two target lesion(s) are being treated, each of these lesions must meet all angiographic inclusion/exclusion criteria
6. Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done ≥ 90 days prior to or if planned to be done 6 months after the index procedure
7. Non-Clinical Investigation percutaneous intervention for lesion in the target vessel is allowed if done \> 6 months prior to or if planned to be done 6 months after the index procedure

General Exclusion Criteria

1. Patients has had a known diagnosis of acute myocardial infarction (AMI) within 3 days preceding the index procedure and creatine kinase (CK) and CK-MB have not returned within normal limits at the time of procedure
2. The patient is currently experiencing clinical symptoms consistent with AMI
3. Patient has current unstable arrhythmias
4. Patient has a known left ventricular ejection fraction (LVEF) \< 30%
5. Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
6. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
7. Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
8. Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
9. Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, poly (L-lactide), poly (DL-lactide) or contrast sensitivity that cannot be adequately pre-medicated
10. Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
11. Patient has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a white blood cell count of \< 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
12. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)
13. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
14. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
15. Patient has had a significant GI or urinary bleed within the past six months
16. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
17. Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
18. Patient is already participating in another clinical investigation that has not yet reached its primary endpoint
19. Pregnant or nursing patients and those who plan pregnancy during the Clinical Investigation. (Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used during participation in this Clinical Investigation)
20. Patient has received brachytherapy in any epicardial vessel (including side branches)

Angiographic Exclusion Criteria

1. Target lesion(s) meets any of the following criteria:

   1. Aorto-ostial location (within 3 mm)
   2. Left main location
   3. Located within 2 mm of the origin of the LAD or LCX
   4. Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and \> 20% stenosed lesion, by visual estimation) arterial or saphenous vein graft
   5. Lesion involving a bifurcation ≥ 2 mm in diameter and ostial lesion \> 40% stenosed by visual estimation or side branch requiring predilatation
   6. Total occlusion (TIMI flow 0), prior to wire crossing
   7. Excessive tortuosity proximal to or within the lesion
   8. Extreme angulation (≥ 90%) proximal to or within the lesion
   9. Heavy calcification
   10. Restenotic from previous intervention
2. The target vessel contains visible thrombus
3. Another clinically significant lesion is located in the same major epicardial vessel as the target lesion(s) (including side branches)
4. Patient has a high probability that a procedure other than pre-dilatation and stenting and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)

Primary outcomes:
measure: Hierarchical Major Adverse Cardiac Event (MACE)
timeFrame: 30 days
measure: Hierarchical Major Adverse Cardiac Event (MACE)
timeFrame: 1 year
measure: In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days
timeFrame: 180 days
measure: In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year
timeFrame: 1 year
Secondary outcomes:
measure: Clinical Device Success (Per Lesion)
timeFrame: On day 0 (the day of procedure)
measure: Clinical Procedure Success (Per Patient)
timeFrame: On day 0 (the day of procedure)
measure: Hierarchical Major Adverse Cardiac Event (MACE)
timeFrame: 180 days
measure: Hierarchical Major Adverse Cardiac Event (MACE)
timeFrame: 270 days
measure: Hierarchical Major Adverse Cardiac Event (MACE)
timeFrame: 2 years
measure: Hierarchical Major Adverse Cardiac Event (MACE)
timeFrame: 3 years
measure: Hierarchical Major Adverse Cardiac Event (MACE)
timeFrame: 4 years
measure: Hierarchical Major Adverse Cardiac Event (MACE)
timeFrame: 5 years
measure: Hierarchical Target Vessel Failure (TVF)
timeFrame: 30 days
measure: Hierarchical Target Vessel Failure (TVF)
timeFrame: 180 days
measure: Hierarchical Target Vessel Failure (TVF)
timeFrame: 270 days
measure: Hierarchical Target Vessel Failure (TVF)
timeFrame: 1 year
measure: Hierarchical Target Vessel Failure (TVF)
timeFrame: 2 years
measure: Hierarchical Target Vessel Failure (TVF)
timeFrame: 3 years
measure: Hierarchical Target Vessel Failure (TVF)
timeFrame: 4 years
measure: Hierarchical Target Vessel Failure (TVF)
timeFrame: 5 years
measure: Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: 30 days
measure: Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: 180 days
measure: Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: 270 days
measure: Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: 1 year
measure: Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: 2 years
measure: Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: 3 years
measure: Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: 4 years
measure: Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: 5 years
measure: Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 30 days
measure: Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 180 days
measure: Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 270 days
measure: Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 1 year
measure: Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 2 years
measure: Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 3 years
measure: Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 4 years
measure: Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 5 years
measure: Cardiac Death
timeFrame: 30 days
measure: Cardiac Death
timeFrame: 1 year
measure: Cardiac Death
timeFrame: 2 years
measure: Cardiac Death
timeFrame: 3 years
measure: Cardiac Death
timeFrame: 4 years
measure: Cardiac Death
timeFrame: 5 years
measure: Myocardial Infarction
timeFrame: 30 days
measure: Myocardial Infarction
timeFrame: 1 year
measure: Myocardial Infarction
timeFrame: 2 years
measure: Myocardial Infarction
timeFrame: 3 years
measure: Myocardial Infarction
timeFrame: 4 years
measure: Myocardial Infarction
timeFrame: 5 years
measure: Scaffold Thrombosis
timeFrame: 30 days
measure: Scaffold Thrombosis
timeFrame: 1 year
measure: Scaffold Thrombosis
timeFrame: 2 years
measure: Scaffold Thrombosis
timeFrame: 3 years
measure: Scaffold Thrombosis
timeFrame: 4 years
measure: Scaffold Thrombosis
timeFrame: 5 years
measure: In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years
timeFrame: 2 years
measure: In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years
timeFrame: 3 years
measure: In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years
timeFrame: 5 years
measure: Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days
timeFrame: 180 days
measure: Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year
timeFrame: 1 year
measure: Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years
timeFrame: 2 years
measure: Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years
timeFrame: 3 years
measure: Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years
timeFrame: 5 years
measure: Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days
timeFrame: 180 days
measure: Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year
timeFrame: 1 year
measure: Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years
timeFrame: 2 years
measure: Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years
timeFrame: 3 years
measure: Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years
timeFrame: 5 years
measure: In-scaffold Angiographic Binary Restenosis (ABR)
timeFrame: 180 days
measure: In-scaffold Angiographic Binary Restenosis (ABR)
timeFrame: 1 year
measure: In-scaffold Angiographic Binary Restenosis (ABR)
timeFrame: 2 years
measure: In-scaffold Angiographic Binary Restenosis (ABR)
timeFrame: 3 years
measure: In-scaffold Angiographic Binary Restenosis (ABR)
timeFrame: 5 years
measure: Persisting Dissection
timeFrame: 180 days
measure: Persisting Dissection
timeFrame: 1 year
measure: Persisting Dissection
timeFrame: 2 years
measure: Persisting Dissection
timeFrame: 3 years
measure: Persisting Dissection
timeFrame: 5 years
measure: In-scaffold Percent Diameter Stenosis (%DS)
timeFrame: 180 days
measure: In-scaffold Percent Diameter Stenosis (%DS)
timeFrame: 1 year
measure: In-scaffold Percent Diameter Stenosis (%DS)
timeFrame: 2 years
measure: In-scaffold Percent Diameter Stenosis (%DS)
timeFrame: 3 years
measure: In-scaffold Percent Diameter Stenosis (%DS)
timeFrame: 5 years
measure: Aneurysm
timeFrame: 180 days
measure: Aneurysm
timeFrame: 1 year
measure: Aneurysm
timeFrame: 2 years
measure: Aneurysm
timeFrame: 3 years
measure: Aneurysm
timeFrame: 5 years
measure: Thrombus
timeFrame: 180 days
measure: Thrombus
timeFrame: 1 year
measure: Thrombus
timeFrame: 2 years
measure: Thrombus
timeFrame: 3 years
measure: Thrombus
timeFrame: 5 years
measure: Vasomotion Analysis: In-scaffold Mean Luminal Diameter
timeFrame: 5 years
measure: Volume Obstruction (VO)
timeFrame: 180 days
measure: Volume Obstruction (VO)
timeFrame: 1 year
measure: Volume Obstruction (VO)
timeFrame: 2 year
measure: Volume Obstruction (VO)
timeFrame: 3 year
measure: Persisting Incomplete Apposition
timeFrame: 180 days
measure: Persisting Incomplete Apposition
timeFrame: 1 year
measure: Persisting Incomplete Apposition
timeFrame: 2 year
measure: Persisting Incomplete Apposition
timeFrame: 3 year
measure: Late Incomplete Apposition
timeFrame: 180 days
measure: Late Incomplete Apposition
timeFrame: 1 year
measure: Late Incomplete Apposition
timeFrame: 2 year
measure: Late Incomplete Apposition
timeFrame: 3 year
Other outcomes:
measure: Mean Reference Area
timeFrame: 1 year
measure: Mean Reference Area
timeFrame: 2 years
measure: Mean Reference Area
timeFrame: 3 years
measure: Mean Reference Area
timeFrame: 5 years
measure: Mean Luminal Area
timeFrame: 1 year
measure: Mean Luminal Area
timeFrame: 2 years
measure: Mean Luminal Area
timeFrame: 3 years
measure: Mean Luminal Area
timeFrame: 5 years
measure: Minimum Luminal Area
timeFrame: 1 year
measure: Minimum Luminal Area
timeFrame: 2 years
measure: Minimum Luminal Area
timeFrame: 3 years
measure: Minimum Luminal Area
timeFrame: 5 years
measure: Mean Stent Area
timeFrame: 1 year
measure: Mean Scaffold Area
timeFrame: 2 years
measure: Mean Scaffold Area
timeFrame: 3 years
measure: Minimum Stent Area
timeFrame: 1 year
measure: Minimum Scaffold Area
timeFrame: 2 year
measure: Minimum Scaffold Area
timeFrame: 3 years
measure: Luminal Volume
timeFrame: 1 year
measure: Luminal Volume
timeFrame: 2 years
measure: Luminal Volume
timeFrame: 3 years
measure: Luminal Volume
timeFrame: 5 years
measure: Stent Volume
timeFrame: 1 year
measure: Scaffold Volume
timeFrame: 2 years
measure: Scaffold Volume
timeFrame: 3 years
measure: Mean Luminal Diameter
timeFrame: 1 year
measure: Mean Luminal Diameter
timeFrame: 2 years
measure: Mean Luminal Diameter
timeFrame: 3 years
measure: Mean Luminal Diameter
timeFrame: 5 years
measure: Minimum Luminal Diameter (MLD)
timeFrame: 1 year
measure: Minimum Luminal Diameter
timeFrame: 2 years
measure: Minimum Luminal Diameter
timeFrame: 3 years
measure: Minimum Luminal Diameter
timeFrame: 5 years
measure: Mean Stent Diameter
timeFrame: 1 year
measure: Mean Scaffold Diameter
timeFrame: 2 years
measure: Mean Scaffold Diameter
timeFrame: 3 years
measure: Minimum Stent Diameter
timeFrame: 1 year
measure: Minimum Scaffold Diameter
timeFrame: 2 years
measure: Minimum Scaffold Diameter
timeFrame: 3 years
measure: Strut Volume
timeFrame: 1 year
measure: Strut Volume
timeFrame: 2 years
measure: Strut Volume
timeFrame: 3 years
measure: Number of Struts Per BVS
timeFrame: 1 year
measure: Number of Struts Per BVS
timeFrame: 2 years
measure: Number of Struts Per BVS
timeFrame: 3 years
measure: Number of Struts Per BVS
timeFrame: 5 years
measure: % of Covered Struts (150 µm)
timeFrame: 1 year
measure: % of Acutely Covered Struts
timeFrame: 2 years
measure: % of Acutely Covered Struts
timeFrame: 3 years
measure: % of Uncovered Struts (150 µm)
timeFrame: 1 year
measure: % of Uncovered Struts (150 µm)
timeFrame: 2 years
measure: % of Uncovered Struts (150 µm)
timeFrame: 3 years
measure: Number of Struts in Side Branch
timeFrame: 1 year
measure: Number of Struts in Side Branch
timeFrame: 2 years
measure: Number of Struts in Side Branch
timeFrame: 3 years
measure: Number of Struts in Side Branch
timeFrame: 5 years
measure: Tissue Coverage Area Classical
timeFrame: 1 year
measure: Tissue Coverage Area BVS (Neointimal Area)
timeFrame: 1 year
measure: Tissue Coverage Volume Classical
timeFrame: 1 year
measure: Tissue Coverage Volume BVS
timeFrame: 1 year
measure: Tissue Coverage Obstruction Volume Classical
timeFrame: 1 year
measure: Tissue Coverage Obstruction Volume BVS
timeFrame: 1 year
measure: Tissue Coverage Area Classical
timeFrame: 2 years
measure: Tissue Coverage Area BVS (Neointimal Area)
timeFrame: 2 years
measure: Tissue Coverage Volume Classical
timeFrame: 2 years
measure: Tissue Coverage Volume BVS
timeFrame: 2 years
measure: Tissue Coverage Obstruction Volume Classical
timeFrame: 2 years
measure: Tissue Coverage Obstruction Volume BVS
timeFrame: 2 years
measure: Tissue Coverage Area Classical
timeFrame: 3 years
measure: Tissue Coverage Area BVS (Neointimal Area)
timeFrame: 3 years
measure: Tissue Coverage Volume Classical
timeFrame: 3 years
measure: Tissue Coverage Volume BVS
timeFrame: 3 years
measure: Tissue Coverage Obstruction Volume Classical
timeFrame: 3 years
measure: Tissue Coverage Obstruction Volume BVS
timeFrame: 3 years
measure: Mean Flow Area
timeFrame: 1 year
measure: Minimum Flow Area
timeFrame: 1 year
measure: Mean Strut Core Area
timeFrame: 1 year
measure: Percent (%) Lumen Area Stenosis
timeFrame: 1 year
measure: Mean Flow Area
timeFrame: 2 years
measure: Minimum Flow Area
timeFrame: 2 years
measure: Mean Strut Core Area
timeFrame: 2 years
measure: Percent (%) Lumen Area Stenosis
timeFrame: 2 years
measure: Mean Flow Area
timeFrame: 3 years
measure: Minimum Flow Area
timeFrame: 3 years
measure: Mean Strut Core Area
timeFrame: 3 years
measure: Percent (%) Lumen Area Stenosis
timeFrame: 3 years
measure: Mean Flow Area
timeFrame: 5 years
measure: Minimum Flow Area
timeFrame: 5 years
measure: Percent (%) Lumen Area Stenosis
timeFrame: 5 years
Locations:
city: Melbourne
country: Australia
facility: St. Vincent's Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Monash Heart
city: Aalst
country: Belgium
facility: Onze-Lieve VrouweZiekenhuis
city: Aarhus
country: Denmark
facility: Skejby Sygehus
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier
city: Eindhoven
country: Netherlands
facility: Catharina ZH Eindhoven
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Krakow
country: Poland
facility: Jagiellonian University
city: Bern
country: Switzerland
facility: Inselspital Bern, Kardiologie
Study officials:
affiliation: Erasmus Heart Center, Thorax Centrum
name: Patrick Serruys, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Auckland City Hospital
name: John Ormiston, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeng Y, Cavalcante R, Collet C, Tenekecioglu E, Sotomi Y, Miyazaki Y, Katagiri Y, Asano T, Abdelghani M, Nie S, Bourantas CV, Bruining N, Onuma Y, Serruys PW. Coronary calcification as a mechanism of plaque/media shrinkage in vessels treated with bioresorbable vascular scaffold: A multimodality intracoronary imaging study. Atherosclerosis. 2018 Feb;269:6-13. doi: 10.1016/j.atherosclerosis.2017.11.002. Epub 2017 Dec 2.
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citation: Zhang YJ, Iqbal J, Nakatani S, Bourantas CV, Campos CM, Ishibashi Y, Cho YK, Veldhof S, Wang J, Onuma Y, Garcia-Garcia HM, Dudek D, van Geuns RJ, Serruys PW; ABSORB Cohort B Study Investigators. Scaffold and edge vascular response following implantation of everolimus-eluting bioresorbable vascular scaffold: a 3-year serial optical coherence tomography study. JACC Cardiovasc Interv. 2014 Dec;7(12):1361-9. doi: 10.1016/j.jcin.2014.06.025. Epub 2014 Nov 12.
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