ABSORB Clinical Investigation, Cohort B (ABSORB B)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00856856
First received: February 27, 2009
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Device: Bioabsorbable Everolimus Eluting Coronary Stent
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Secondary Outcome Measures:
  • In-stent Late Loss (LL) [ Time Frame: at 180 days, 1, 2, 3, and 5 years ] [ Designated as safety issue: No ]
  • In-segment LL [ Time Frame: at 180 days, 1, 2, 3, and 5 years ] [ Designated as safety issue: No ]
  • Proximal LL (proximal defined as within 5 mm of tissue proximal to stent placement) [ Time Frame: at 180 days, 1, 2, 3, and 5 years ] [ Designated as safety issue: No ]
  • Distal LL (distal defined as within 5 mm of tissue distal to stent placement) [ Time Frame: at 180 days, 1, 2, 3, and 5 years ] [ Designated as safety issue: No ]
  • In-stent and in-segment Angiographic Binary Restenosis (ABR) rate [ Time Frame: at 180 days, 1, 2, 3, and 5 years ] [ Designated as safety issue: No ]
  • In-stent % Volume Obstruction (VO) [ Time Frame: at 180 days, 1, 2, 3, and 5 years ] [ Designated as safety issue: No ]
  • Persisting incomplete apposition, late incomplete apposition, aneurysm, thrombus, persisting dissection [ Time Frame: at 180 days, 1, 2, 3, and 5 years ] [ Designated as safety issue: No ]
  • Ischemia Driven Major Adverse Cardiac Events (ID-MACE) [ Time Frame: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years ] [ Designated as safety issue: Yes ]
  • Ischemia driven Target Vessel Failure (ID-TVF) [ Time Frame: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years ] [ Designated as safety issue: No ]
  • Acute success (clinical device and clinical procedure) [ Time Frame: Acute ] [ Designated as safety issue: No ]
  • Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: at 30, 180, 270 days and 1, 2, 3, 4, 5 years ] [ Designated as safety issue: No ]
  • Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: at 30, 180, 270 days and 1, 2, 3, 4, 5 years ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABSORB stent
Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)
Device: Bioabsorbable Everolimus Eluting Coronary Stent
Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 CSSand 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, IVUS, Palpography (optional), OCT (strongly recommended), 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 (LAD with septal and diagonal branches, LCX with obtuse marginal and/or ramus intermedius branches and 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 listed under 5.3.2 and 5.3.4
  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 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 WBC 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 (Extreme angulation (≥ 90%) proximal to or within the lesion (Heavy calcification (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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856856

Locations
Australia, Victoria
St. Vincent's Hospital
Melbourne, Victoria, Australia, 3065
Australia
Monash Heart
Melbourne, Australia
Belgium
Onze-Lieve VrouweZiekenhuis
Aalst, Belgium
Denmark
Skejby Sygehus
Aarhus, Denmark
France
Institut Hospitalier Jacques Cartier
Massy, France
Netherlands
Catharina ZH Eindhoven
Eindhoven, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
New Zealand
Auckland City Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Poland
Jagiellonian University
Krakow, Poland
Switzerland
Inselspital Bern, Kardiologie
Bern, Switzerland, 3010
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Patrick Serruys, MD Erasmus Heart Center, Thorax Centrum
Principal Investigator: John Ormiston, MD Auckland City Hospital
  More Information

Additional Information:
No publications provided by Abbott Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00856856     History of Changes
Other Study ID Numbers: 05-370 Cohort B
Study First Received: February 27, 2009
Last Updated: April 2, 2014
Health Authority: New Zealand: Health and Disability Ethics Committees

Keywords provided by Abbott Vascular:
Bioabsorbable
Coronary Stent
Everolimus
drug eluting stents
stents
angioplasty
coronary artery disease
total coronary occlusion
coronary artery restenosis
stent thrombosis
vascular disease
myocardial ischemia
coronary artery stenosis
CAD
CAOD

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Stenosis
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 01, 2014