The Intra-Drug Eluting Stent (DES) Restenosis Study (CRISTAL)

July 28, 2010 updated by: Cordis Corporation

A Prospective, Randomized, Multi-Center Comparison of the CYPHER Select™ Sirolimus-Eluting Stent and Balloon Re-Angioplasty for Treatment of Patients With Intra-Des Restenosis

A Prospective, Randomized, Multi-Center Comparison of the Cypher Select™ Sirolimus-Eluting Stent and Balloon Re-Angioplasty for Treatment of Patients with Intra-Des Restenosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized study to be conducted at up to 33 sites in France with 3 groups of patients (1 group with intra-Taxus™ restenosis, 1 group with intra-Cypher™ restenosis and 1 control group with intra-BMS restenosis). All patients will have a repeat angiography at 9 to 12 months post-procedure and will be followed up to 12 months post-procedure.

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 4

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

  • France
      • Saint Denis, France
        • Centre Cardiologique du Nord
      • Toulouse Cedex 3, France, 4131076
        • Unite de Cardiologie Interventionelle

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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-III) OR patients with documented silent ischemia;
  • Patient has an intra-DES (TAXUS™ OR CYPHER™) or intra-BMS restenosis of >= 50% and <100% (by QCA online of the MLD compared to the distal reference diameter) in a native coronary artery;
  • Study target lesion must be located in a restenotic native coronary artery >=2.25mm and <=3.5mm in lumen diameter and <=30mm in length by visual estimate and within a region up to 5mm to the proximal/distal stent edge;
  • Study target lesion must have undergone coronary interventional treatment >= 4 weeks previously. Patients with one ore more prior PTCA procedures at the target lesion are acceptable candidates.
  • Study target lesion can not be located in a vessel containing another lesion requiring treatment. Lesions located in other vessels may be treated with percutaneous revascularization at the time of the procedure, BUT they must be successfully treated prior to the treatment of the study target lesion;
  • Patient is candidate for a current percutaneous revascularisation technique;
  • Patient is willing to comply with the specified follow-up evaluations (including angiographic follow-up);
  • Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee;

Exclusion Criteria:

  • Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK >2 times normal within the preceding 72 hours and the CK enzymes remain above normal at the time of treatment;
  • Has unstable angina classified as Braunwald A I-II-III;
  • Unprotected left main coronary disease with ³50% stenosis;
  • Significant (>50%) stenoses of additional lesions proximal or distal to the target lesion(s) that might require revascularization or impede runoff;
  • Target lesion is in an internal mammary artery, saphenous vein bypass graft or is located in the left main or is ostial;
  • Stent implantation(s) is a non-elective, emergency procedure;
  • Stent at the target restenosed lesion is neither TAXUS™ , CYPHER™ DES nor a BMS;
  • Documented left ventricular ejection fraction <=25%;
  • Totally occluded vessel (TIMI 0 level).

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
group with intra-Cypher™ restenosis
Device: drug-eluting stent and balloon angioplasty
CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand
ACTIVE_COMPARATOR: 2
group with intra-Taxus™ restenosis
Device: drug-eluting stent and balloon angioplasty
CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand
ACTIVE_COMPARATOR: 3
group with intra-BMS restenosis
Device: drug-eluting stent
CYPHER Select ™ Sirolimus-eluting Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In stent late loss.
Time Frame: between 9 - 12 months
between 9 - 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
In-stent, in-segment, and in-lesion binary restenosis rate by QCA.
Time Frame: between 9 - 12 months
between 9 - 12 months
In-lesion late loss as assessed by QCA.
Time Frame: between 9 - 12 months
between 9 - 12 months
In-stent and in-lesion MLD, and percent diameter stenosis (%DS) as assessed by QCA.
Time Frame: between 9 - 12 months
between 9 - 12 months
Target lesion revascularization (TLR).
Time Frame: 30 days, 6 and 12 months
30 days, 6 and 12 months
Target vessel revascularization (TVR).
Time Frame: 30 days, 6 and 12 months
30 days, 6 and 12 months
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization.
Time Frame: 30 days, 6 and 12 months
30 days, 6 and 12 months
Composite of Major Adverse Cardiac Events (MACE) defined as cardiac death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization.
Time Frame: 30 days, 6 months and 12 months
30 days, 6 months and 12 months

Collaborators and Investigators

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

Sponsor

Cordis Corporation

Investigators

  • Principal Investigator: Bernard Chevalier, MD, Centre Cardiologique du Nord, Saint Denis, France
  • Principal Investigator: Jean Fajadet, MD, PhD, Unité de Cardiologie Interventionnelle, Toulouse Cedex 3, France

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

March 1, 2006

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

May 9, 2006

First Submitted That Met QC Criteria

May 9, 2006

First Posted (ESTIMATE)

May 10, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 29, 2010

Last Update Submitted That Met QC Criteria

July 28, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC05-02

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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