Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents (VELETI II)

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Status and phase

Terminated

Phase 4

Conditions

Coronary Artery Bypass Grafting

Treatments

Device: Paclitaxel eluting stent

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01223443

VELETI II

Details and patient eligibility

About

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 objective: To evaluate the efficacy of stenting moderate SVG lesions with paclitaxel-eluting stents on reducing the first occurrence of the composite of cardiac death, myocardial infarction or repeat revascularization related to the target SVG over the duration of follow-up (minimun of 2-year follow-up.

Full 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 atherosclerosis progression and cardiac events at follow-up. Patients with previous coronary bypass surgery with SVG implantation undergoing coronary angiography by clinical indication will be screened. If the patient has a moderate lesion at any level of the SVGs it will be includable in the study. After inclusion, the patients will be randomized to either stenting the moderate SVG lesion with the taxus stent or standard medical treatment. Following this procedure, all patients will have follow-up visits by telephone or clinic at 30 days, 180 days, 1 year, and yearly until the common study end date. The duration of the study will be approximately 4 years with a minimun of 2-year follow-up.

Enrollment

125 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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