ABSORB Clinical Investigation, Cohort B (ABSORB B)

Abbott

Status: Completed

Conditions: Coronary Artery Disease; Coronary Restenosis; Coronary Disease

Treatments: Device: Bioabsorbable Everolimus Eluting Coronary Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00856856

05-370 Cohort B

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

Absorb stent

Experimental group

Description:

Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)

Treatment:

Device: Bioabsorbable Everolimus Eluting Coronary Stent