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

NCT ID: NCT00263263

Last Updated: 2007-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2005-12-31

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).

Conditions

Stable Angina; Unstable Angina; Coronary Artery Disease; Saphenous Vein Graft Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

sirolimus-eluting stent

Intervention Type: DEVICE

bare metal stent

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antwerp Cardiovascular Institute Middelheim

OTHER

Sponsor Role: lead

Principal Investigators

Paul Vermeersch, MD

Role: PRINCIPAL_INVESTIGATOR

Antwerp Cardiovascular Institute Middelheim

Glenn Vanlangenhove, MD, PhD

Role: STUDY_CHAIR

Antwerp Cardiovascular Institute Middelheim

Pierfrancesco Agostoni, MD

Role: STUDY_DIRECTOR

Antwerp Cardiovascular Institute Middelheim

Locations

Antwerp Cardiovascular Institute Middelheim

Antwerp, , Belgium

Countries

Belgium

References

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. doi: 10.1016/j.jacc.2007.05.010. Epub 2007 Jun 13.

Reference Type: DERIVED

PMID: 17631219 (View on PubMed)

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. doi: 10.1016/j.jacc.2006.09.021. Epub 2006 Nov 28.

Reference Type: DERIVED

PMID: 17174178 (View on PubMed)

Other Identifiers

INCUBATE-001

Identifier Type: -

Identifier Source: org_study_id