The Intra-Drug Eluting Stent (DES) Restenosis Study

NCT ID: NCT00323895

Last Updated: 2010-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2010-01-31

Brief Summary

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

group with intra-Cypher™ restenosis

Group Type: EXPERIMENTAL

drug-eluting stent and balloon angioplasty

Intervention Type: DEVICE

CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand

2

group with intra-Taxus™ restenosis

Group Type: ACTIVE_COMPARATOR

drug-eluting stent and balloon angioplasty

Intervention Type: DEVICE

CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand

3

group with intra-BMS restenosis

Group Type: ACTIVE_COMPARATOR

drug-eluting stent

Intervention Type: DEVICE

CYPHER Select ™ Sirolimus-eluting Stent

Interventions

drug-eluting stent and balloon angioplasty

CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand

Intervention Type: DEVICE

drug-eluting stent and balloon angioplasty

CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand

Intervention Type: DEVICE

drug-eluting stent

CYPHER Select ™ Sirolimus-eluting Stent

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cordis Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Cordis

Principal Investigators

Bernard Chevalier, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Cardiologique du Nord, Saint Denis, France

Jean Fajadet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Unité de Cardiologie Interventionnelle, Toulouse Cedex 3, France

Locations

Centre Cardiologique du Nord

Saint-Denis, , France

Unite de Cardiologie Interventionelle

Toulouse, , France

Countries

France

References

Chevalier B, Moulichon R, Teiger E, Brunel P, Metzger JP, Pansieri M, Carrie D, Stoll HP, Wittebols K, Spaulding C, Fajadet J; Cristal Investigators. One-year results of the CRISTAL Trial, a randomized comparison of cypher sirolimus-eluting coronary stents versus balloon angioplasty for restenosis of drug-eluting stents. J Interv Cardiol. 2012 Dec;25(6):586-95. doi: 10.1111/j.1540-8183.2012.00769.x. Epub 2012 Sep 20.

Reference Type: DERIVED

PMID: 22994863 (View on PubMed)

Other Identifiers

EC05-02

Identifier Type: -

Identifier Source: org_study_id