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

March 12, 2007 updated by: Antwerp Cardiovascular Institute Middelheim

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2020
        • Antwerp Cardiovascular Institute Middelheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
In-stent late loss

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

December 7, 2005

First Submitted That Met QC Criteria

December 7, 2005

First Posted (Estimate)

December 8, 2005

Study Record Updates

Last Update Posted (Estimate)

March 14, 2007

Last Update Submitted That Met QC Criteria

March 12, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCUBATE-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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