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

Cordis

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: drug-eluting stent; Device: drug-eluting stent and balloon angioplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT00323895

EC05-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

320 participants in 3 patient groups

1

Experimental group

Description:

group with intra-Cypher™ restenosis

Treatment:

Device: drug-eluting stent and balloon angioplasty

Device: drug-eluting stent and balloon angioplasty

2

Active Comparator group

Description:

group with intra-Taxus™ restenosis

Treatment:

Device: drug-eluting stent and balloon angioplasty

Device: drug-eluting stent and balloon angioplasty

3

Active Comparator group

Description:

group with intra-BMS restenosis

Treatment:

Device: drug-eluting stent