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Completed

NCT Number: NCT00263263

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

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).

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Key information

Conditions

Stable Angina Angina Pectoris Angina, Stable Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Saphenous Vein Graft Disease Signs and Symptoms Unstable Angina Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Antwerp Cardiovascular Institute Middelheim

Antwerp, 2020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sirolimus-eluting stent

Device

Bare Metal Stent

Device

Primary outcomes

  1. In-stent late loss

Secondary outcomes

  1. in-segment late loss

  2. binary angiographic in-stent restenosis

  3. binary angiographic in-segment restenosis

  4. intravascular-ultrasound-measured neo-intimal hyperplasia volume

  5. death

  6. myocardial infarction

  7. target-lesion revascularization

  8. target-vessel revascularization

  9. stent thrombosis

Sponsors and collaborators

Lead sponsor

Antwerp Cardiovascular Institute Middelheim

Other

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2005
First posted
Dec 8, 2005
Registry last updated
Mar 14, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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