The Intra-Drug Eluting Stent (DES) Restenosis Study

Coronary Artery Disease Clinical Trial

— CRISTAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323895
• Other study ID #: EC05-02
• Status: Completed
• Phase: Phase 4
• First received: May 9, 2006
• Last updated: July 28, 2010
• Start date: March 2006
• Est. completion date: January 2010

Study information

• Verified date: July 2010
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: CCPPRB
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• drug-eluting stent and balloon angioplasty
CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand
• drug-eluting stent and balloon angioplasty
CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand
• drug-eluting stent
CYPHER Select ™ Sirolimus-eluting Stent

Locations

Country	Name	City	State
France	Centre Cardiologique du Nord	Saint Denis
France	Unite de Cardiologie Interventionelle	Toulouse Cedex 3

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

France, 

Outcome

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