MedDataX Logo

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

NCT ID: NCT00234455

Last Updated: 2008-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2007-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective, randomized study that will be conducted at up to 5 centers in Europe and the US. All patients who meet the eligibility criteria will be treated with the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent and Stent Delivery System (SDS). As a secondary objective, patients will be randomized in a 1:1 ratio to receive one stent in the main branch with balloon angioplasty by a kissing balloon technique in the side branch (stent/PTCA group), or to receive stents in both the main and side branches (stent/stent group). It is anticipated that up to 70% of the patients enrolled in the stent/PTCA group will be considered treatment failures and require a stent in the side branch. These patients will have a sirolimus-coated stent placed in the side branch and will be followed per the protocol, but will be analyzed separately. Therefore, it is anticipated that up to 75 patients will be enrolled in the trial. All patients will have repeat angiography at six months, with clinical follow-up to 5 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

Group Type OTHER

drug eluting-stent

Intervention Type DEVICE

PCI

2

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

Group Type OTHER

drug-eluting stent

Intervention Type DEVICE

PCI

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

drug eluting-stent

PCI

Intervention Type DEVICE

drug-eluting stent

PCI

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

sirolimus-coated Bx VELOCITY Balloon-Expandable Stent sirolimus-coated Bx VELOCITY Balloon-Expandable Stent

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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;
2. 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;
3. Has a true bifurcation lesion defined as stenosis \> 50% in both the main branch and the ostium of the side branch;
4. Has a main branch vessel that is \<=2.5 mm and \<=3.5 mm in diameter by on-line QCA proximal to the bifurcation;
5. Has a side branch vessel that is \<=2.5 mm and \<=3.5 mm in diameter by on-line QCA.

Exclusion Criteria

1. 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;
2. Has unstable angina classified as Braunwald A I-III, or III B or C, or is having a peri infarction;
3. Has a bifurcation lesion in a non protected left main;
4. Has an ejection fraction \<=35%;
5. There is presence of thrombus in the bifurcation lesion;
6. Has a totally occluded vessel.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cordis Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cordis

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Antonio Colombo, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Cuore Columbus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Cuore Columbus

Milan, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EC01-02

Identifier Type: -

Identifier Source: org_study_id