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

Sponsored by:	Antwerp Cardiovascular Institute Middelheim
Information provided by:	Antwerp Cardiovascular Institute Middelheim
ClinicalTrials.gov Identifier:	NCT00263263

Purpose

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	Intervention	Phase
Stable Angina Unstable Angina Coronary Artery Disease Saphenous Vein Graft Disease	Device: sirolimus-eluting stent Device: bare metal stent	Phase II

MedlinePlus related topics: Angina Coronary Artery Disease Heart Attack

Drug Information available for: Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Phase 2 Randomized Double-Blind Comparison of Sirolimus-Eluting Stent Versus Bare-Metal Stent Implantation in Degenerated Saphenous Vein Grafts

Further study details as provided by Antwerp Cardiovascular Institute Middelheim:

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

Estimated Enrollment:	75
Study Start Date:	September 2003
Estimated Study Completion Date:	December 2005

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263263

Locations

Belgium
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

More Information

Publications indexed to this study:

Vermeersch P, Agostoni P, Verheye S, Van den Heuvel P, Convens C, Van den Branden F, Van Langenhove G; DELAYED RRISC (Death and Events at Long-term follow-up AnalYsis: Extended Duration of the Reduction of Restenosis In Saphenous vein grafts with Cypher stent) Investigators. Increased late mortality after sirolimus-eluting stents versus bare-metal stents in diseased saphenous vein grafts: results from the randomized DELAYED RRISC Trial. J Am Coll Cardiol. 2007 Jul 17;50(3):261-7. Epub 2007 Jun 13.

Vermeersch P, Agostoni P, Verheye S, Van den Heuvel P, Convens C, Bruining N, Van den Branden F, Van Langenhove G. Randomized double-blind comparison of sirolimus-eluting stent versus bare-metal stent implantation in diseased saphenous vein grafts: six-month angiographic, intravascular ultrasound, and clinical follow-up of the RRISC Trial. J Am Coll Cardiol. 2006 Dec 19;48(12):2423-31. Epub 2006 Nov 28.

Study ID Numbers:	INCUBATE-001
Study First Received:	December 7, 2005
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00263263
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

Study placed in the following topic categories:

Sirolimus
Arterial Occlusive Diseases
Heart Diseases
Clotrimazole
Miconazole
Myocardial Ischemia
Tioconazole
Angina Pectoris
Vascular Diseases

Pain
Ischemia
Arteriosclerosis
Chest Pain
Coronary Disease
Signs and Symptoms
Angina, Unstable
Coronary Artery Disease

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents
Therapeutic Uses

Physiological Effects of Drugs
Cardiovascular Diseases
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009