A Study of the Cypher Sirolimus-Eluting Stent to Treat Bifurcation Lesions.

NCT00234455 | Completed Phase 2 DMC

• 1 other identifier: EC01-02
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the feasibility and safety of the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent in treating patients with true bifurcation lesions.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• percent residual diameter stenosis (%DS) in the stented branch as measured by quantitative coronary angiography (QCA)

  6-months post-procedure

Secondary Outcomes (4)

• device success defined as achievement of a final residual diameter stenosis of < 50% (by QCA), using the assigned device/treatment only

  anytime during the course of the study

• procedure success defined as achievement of a final diameter stenosis of < 50% (by QCA) using any percutaneous method, without the occurrence of death, myocardial infarction (MI), or repeat revascularization of the target lesion during the hospital stay

  anytime during the course of the study

• target vessel failure (TVF), defined as a composite of cardiac death, MI, or target vessel revascularization

  6, 12, 18, and 24 months post-procedure

• lumen and obstruction volume by intravascular ultrasound (IVUS)

  6-month post-procedure

Study Arms (2)

1

OTHER

stent in the main branch with balloon angioplasty by a kissing balloon technique in the side branch (stent/PTCA group)

Device: drug eluting-stent

2

OTHER

stents in both the main and side branches (stent/stent group)

Device: drug-eluting stent

Interventions

drug eluting-stent DEVICE

PCI

Also known as: sirolimus-coated Bx VELOCITY Balloon-Expandable Stent

1

drug-eluting stent DEVICE

PCI

Also known as: sirolimus-coated Bx VELOCITY Balloon-Expandable Stent

2

Eligibility Criteria

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

You may qualify if:

• Has a diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR has documented silent ischemia;
• Involves a single treatment of a de novo bifurcation lesion in native coronary arteries of patients with single or multivessel disease; patients with multiple lesions can be included only if other lesions treated during the index procedure are successfully treated prior to the treatment of the bifurcation lesion;
• Has a true bifurcation lesion defined as stenosis \> 50% in both the main branch and the ostium of the side branch;
• Has a main branch vessel that is \<=2.5 mm and \<=3.5 mm in diameter by on-line QCA proximal to the bifurcation;
• Has a side branch vessel that is \<=2.5 mm and \<=3.5 mm in diameter by on-line QCA.

You may not qualify if:

• Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented elevation of CK levels \> 2 times normal or CK-MB levels \> 3 times normal within the preceding 24 hours and/or the CK and CK-MB enzymes remain above normal at the time of treatment;
• Has unstable angina classified as Braunwald A I-III, or III B or C, or is having a peri infarction;
• Has a bifurcation lesion in a non protected left main;
• Has an ejection fraction \<=35%;
• There is presence of thrombus in the bifurcation lesion;
• Has a totally occluded vessel.

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Centre Cuore Columbus

Milan, I-20145, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Antonio Colombo, MD

  Centre Cuore Columbus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 5, 2005
• First Posted: October 7, 2005
• Study Start: June 1, 2001
• Primary Completion: October 1, 2002
• Study Completion: April 1, 2007
• Last Updated: April 30, 2008

Record last verified: 2008-04

Locations

IT (1)