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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00263263
• Other study ID #: INCUBATE-001
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2005
• Last updated: March 12, 2007
• Start date: September 2003
• Est. completion date: December 2005

Study information

• Verified date: March 2007
• Source: Antwerp Cardiovascular Institute Middelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Stable
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Saphenous Vein Graft Disease
• Stable Angina
• Unstable Angina

Intervention

Device:
• sirolimus-eluting stent

• bare metal stent

Locations

Country	Name	City	State
Belgium	Antwerp Cardiovascular Institute Middelheim	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Antwerp Cardiovascular Institute Middelheim

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent late loss
Secondary	in-segment late loss
Secondary	binary angiographic in-stent restenosis
Secondary	binary angiographic in-segment restenosis
Secondary	intravascular-ultrasound-measured neo-intimal hyperplasia volume
Secondary	death
Secondary	myocardial infarction
Secondary	target-lesion revascularization
Secondary	target-vessel revascularization
Secondary	stent thrombosis