RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent.

Sponsor

Antwerp Cardiovascular Institute Middelheim (Other)

Overall Status

Completed

CT.gov ID

NCT00263263

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Context: Sirolimus-eluting-stents have improved the benefits of percutaneous interventions in native coronary arteries reducing the occurrence of restenosis and repeated revascularization, however saphenous vein grafts have been always excluded form randomized trials.

Objective: To evaluate the angiographic and clinical impact of sirolimus-eluting-stents with respect to bare-metal-stents in degenerated vein grafts.

Design: Double-blind randomized controlled non-industry-sponsored trial.

Setting: A single-center tertiary-care referral hospital.

Patients: All patients are randomly allocated to sirolimus-eluting-stent implantation or the corresponding bare-metal-stent. All patients are followed clinically and repeated angiographic follow-up is performed in all at 6-months.

Main outcome measure: Primary end-point is 6-months angiographic in-stent late loss. Secondary end-points include: binary angiographic in-stent and in-segment restenosis, intravascular-ultrasound-measured neo-intimal hyperplasia volume and all the clinical events (death, myocardial infarction, target-lesion and target-vessel revascularization).

Condition or Disease	Intervention/Treatment	Phase
Stable Angina Unstable Angina Coronary Artery Disease Saphenous Vein Graft Disease	Device: sirolimus-eluting stent Device: bare metal stent	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Phase 2 Randomized Double-Blind Comparison of Sirolimus-Eluting Stent Versus Bare-Metal Stent Implantation in Degenerated Saphenous Vein Grafts

Study Start Date :

Sep 1, 2003

Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

In-stent late loss []

Secondary Outcome Measures

in-segment late loss []
binary angiographic in-stent restenosis []
binary angiographic in-segment restenosis []
intravascular-ultrasound-measured neo-intimal hyperplasia volume []
death []
myocardial infarction []
target-lesion revascularization []
target-vessel revascularization []
stent thrombosis []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 to 85 years-old
clear signs and/or symptoms of stable or unstable angina or documented silent ischemia
one or more de-novo target lesions (>50% diameter stenosis by visual estimate) localized in one or more diseased SVG with a reference vessel diameter (RVD) included between 2.5 and 4.0 mm (by visual estimate)
signed informed consent.

Exclusion Criteria:

Myocardial Infarction within the previous 7 days
documented left ventricular ejection fraction <25%
impaired renal function (creatinine >3.0 mg/dl) at the time of treatment
outflow obstruction of the graft due to distal anastomotic stenosis
totally occluded Saphenous Vein Graft
brachytherapy treatment in the index vessel before enrollment
life expectancy less than 12 months
known allergy to aspirin, clopidogrel bisulfate, heparin, stainless steel, contrast agent or sirolimus
hemorrhagic diatheses
a recent positive pregnancy test, breast-feeding, or the possibility of a future pregnancy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Antwerp Cardiovascular Institute Middelheim	Antwerp		Belgium	2020

Sponsors and Collaborators

Antwerp Cardiovascular Institute Middelheim

Investigators

Principal Investigator: Paul Vermeersch, MD, Antwerp Cardiovascular Institute Middelheim
Study Chair: Glenn Vanlangenhove, MD, PhD, Antwerp Cardiovascular Institute Middelheim
Study Director: Pierfrancesco Agostoni, MD, Antwerp Cardiovascular Institute Middelheim