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

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: Coronary Artery Disease
• Intervention / Treatment: Device: drug-eluting stent and balloon angioplasty; Device: drug-eluting stent

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

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.	between 9 - 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
In-stent, in-segment, and in-lesion binary restenosis rate by QCA.	between 9 - 12 months
In-lesion late loss as assessed by QCA.	between 9 - 12 months
In-stent and in-lesion MLD, and percent diameter stenosis (%DS) as assessed by QCA.	between 9 - 12 months
Target lesion revascularization (TLR).	30 days, 6 and 12 months
Target vessel revascularization (TVR).	30 days, 6 and 12 months
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization.	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.	30 days, 6 months and 12 months

Collaborators and Investigators

• 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

General Publications

• 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.

Study record dates

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: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: EC05-02