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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
drug-eluting stent and balloon angioplasty
drug-eluting stent and balloon angioplasty
drug-eluting stent
Sponsored by
Cordis Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Centre Cardiologique du Nord
  • Unite de Cardiologie Interventionelle

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

group with intra-Cypher™ restenosis

group with intra-Taxus™ restenosis

group with intra-BMS restenosis

Outcomes

Primary Outcome Measures

In stent late loss.

Secondary Outcome Measures

In-stent, in-segment, and in-lesion binary restenosis rate by QCA.
In-lesion late loss as assessed by QCA.
In-stent and in-lesion MLD, and percent diameter stenosis (%DS) as assessed by QCA.
Target lesion revascularization (TLR).
Target vessel revascularization (TVR).
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization.
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.

Full Information

First Posted
May 9, 2006
Last Updated
July 28, 2010
Sponsor
Cordis Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00323895
Brief Title
The Intra-Drug Eluting Stent (DES) Restenosis Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cordis Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
group with intra-Cypher™ restenosis
Arm Title
2
Arm Type
Active Comparator
Arm Description
group with intra-Taxus™ restenosis
Arm Title
3
Arm Type
Active Comparator
Arm Description
group with intra-BMS restenosis
Intervention Type
Device
Intervention Name(s)
drug-eluting stent and balloon angioplasty
Intervention Description
CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand
Intervention Type
Device
Intervention Name(s)
drug-eluting stent and balloon angioplasty
Intervention Description
CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand
Intervention Type
Device
Intervention Name(s)
drug-eluting stent
Intervention Description
CYPHER Select ™ Sirolimus-eluting Stent
Primary Outcome Measure Information:
Title
In stent late loss.
Time Frame
between 9 - 12 months
Secondary Outcome Measure Information:
Title
In-stent, in-segment, and in-lesion binary restenosis rate by QCA.
Time Frame
between 9 - 12 months
Title
In-lesion late loss as assessed by QCA.
Time Frame
between 9 - 12 months
Title
In-stent and in-lesion MLD, and percent diameter stenosis (%DS) as assessed by QCA.
Time Frame
between 9 - 12 months
Title
Target lesion revascularization (TLR).
Time Frame
30 days, 6 and 12 months
Title
Target vessel revascularization (TVR).
Time Frame
30 days, 6 and 12 months
Title
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization.
Time Frame
30 days, 6 and 12 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Chevalier, MD
Organizational Affiliation
Centre Cardiologique du Nord, Saint Denis, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean Fajadet, MD, PhD
Organizational Affiliation
Unité de Cardiologie Interventionnelle, Toulouse Cedex 3, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Cardiologique du Nord
City
Saint Denis
Country
France
Facility Name
Unite de Cardiologie Interventionelle
City
Toulouse Cedex 3
ZIP/Postal Code
4131076
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22994863
Citation
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.
Results Reference
derived

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The Intra-Drug Eluting Stent (DES) Restenosis Study

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