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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00323895
First received: May 9, 2006
Last updated: July 28, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
 Device: drug-eluting stent and balloon angioplasty
Device: drug-eluting stent
 Phase 4

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

Resource links provided by NLM:

Drug Information available for: Sirolimus
U.S. FDA Resources

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • In stent late loss. [ Time Frame: between 9 - 12 months ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 320
Study Start Date: March 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323895

Locations
France
Centre Cardiologique du Nord
Saint Denis, France
Unite de Cardiologie Interventionelle
Toulouse Cedex 3, France, 4131076
Sponsors and Collaborators
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
  More Information

No publications provided by Cordis Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Hans-Peter Stoll - WW Leader Cardiology Clinical Research, Cordis
ClinicalTrials.gov Identifier: NCT00323895     History of Changes
Other Study ID Numbers: EC05-02
Study First Received: May 9, 2006
Last Updated: July 28, 2010
Health Authority: France: CCPPRB

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013