Status:
TERMINATED
Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents
Lead Sponsor:
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Collaborating Sponsors:
Boston Scientific Corporation
Canadian Institutes of Health Research (CIHR)
Conditions:
Coronary Artery Bypass Grafting
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Hypothesis: Sealing moderate SVG lesions with paclitaxel-eluting stents reduces cardiac events (death, myocardial infarction, target vessel revascularization) over the duration of follow-up. Primary ...
Detailed Description
This is a prospective, multicenter, randomized study assessing the efficacy of stenting moderate SVG lesions (30% to 60% by visual estimation) with paclitaxel-eluting stents in the prevention of SVG a...
Eligibility Criteria
Inclusion
- Clinical indication for cardiac catheterization and SVG angiography
- Presence of at least one SVG lesion of 30% to 60% diameter stenoses, by visual estimation, which is not the culprit lesion\* responsible for the clinical syndrome of the patient
- \*If the target lesion is located in the same SVG than the culprit lesion (if present) it has to be at least 4 cm far from the stented segment)
- Written informed consent
Exclusion
- Patient \< 18 years old
- Ejection fraction \< 30%
- Renal insufficiency with creatinine \> 200 μmol/l
- Presence of more than 2 moderate SVG stenoses in a single SVG or significant diffuse SVG disease defined as disease covering more than half of the length of the SVG
- Presence of more than 2 SVGs with moderate SVG stenoses
- Unsuccessful angioplasty (residual stenosis \>30% and/or TIMI flow \<3) of any other lesion treated during the same procedure (culprit lesions will be treated before patient randomization)
- Any significant complication occurring during the angioplasty of the culprit lesion(s) during the same procedure
- SVG lesion located at the distal anastomosis
- SVG lesions located at the proximal anastomosis (lesion length \< 5 mm from the SVG ostium)
- Lesion length \>25 mm
- SVGs ≤ 3 years ago
- Cardiogenic shock
- Remaining coronary or SVG lesion(s) with treatment (PCI or CABG) planned within the following year
- Pregnancy
- Contraindication to aspirin and/or thienopyridine/ticagrelor treatment
- Allergy to paclitaxel
- Any disease with a limiting life-expectancy (less than 2 years)
- Need for chronic anticoagulation treatment
- Definite presence or high suspicion of thrombus or ulceration in the target lesion
- Target lesion located in the same SVG as the culprit lesion (if present) and distance between the target lesion and the most proximal or distal part of the stent implanted at the culprit lesion \< 4 cm
- Vein graft diameter \< 2.5 mm
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01223443
Start Date
April 1 2010
End Date
September 1 2016
Last Update
October 27 2016
Active Locations (1)
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1
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5