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

NCT00263263 | Completed Phase 2 DMC

• 1 other identifier: INCUBATE-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• In-stent late loss

Secondary Outcomes (9)

• in-segment late loss

• binary angiographic in-stent restenosis

• binary angiographic in-segment restenosis

• intravascular-ultrasound-measured neo-intimal hyperplasia volume

• death

Interventions

sirolimus-eluting stent DEVICE

bare metal stent DEVICE

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antwerp Cardiovascular Institute Middelheim: lead

Study Sites (1)

Antwerp Cardiovascular Institute Middelheim

Antwerp, 2020, Belgium

Location

Related Publications (2)

• 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.

  PMID: 17631219 DERIVED

• 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.

  PMID: 17174178 DERIVED

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Paul Vermeersch, MD

  Antwerp Cardiovascular Institute Middelheim

  PRINCIPAL INVESTIGATOR

• Glenn Vanlangenhove, MD, PhD

  Antwerp Cardiovascular Institute Middelheim

  STUDY CHAIR

• Pierfrancesco Agostoni, MD

  Antwerp Cardiovascular Institute Middelheim

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2005
• First Posted: December 8, 2005
• Study Start: September 1, 2003
• Study Completion: December 1, 2005
• Last Updated: March 14, 2007

Record last verified: 2007-03

Locations

BE (1)