The Intra-Drug Eluting Stent (DES) Restenosis Study

NCT00323895 | Completed Phase 4 DMC

• 1 other identifier: EC05-02
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• In stent late loss.

  between 9 - 12 months

Secondary Outcomes (7)

• 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

Study Arms (3)

1

EXPERIMENTAL

group with intra-Cypher™ restenosis

Device: drug-eluting stent and balloon angioplasty

2

ACTIVE COMPARATOR

group with intra-Taxus™ restenosis

Device: drug-eluting stent and balloon angioplasty

3

ACTIVE COMPARATOR

group with intra-BMS restenosis

Device: drug-eluting stent

Interventions

drug-eluting stent and balloon angioplasty DEVICE

CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand

1

drug-eluting stent DEVICE

CYPHER Select ™ Sirolimus-eluting Stent

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (2)

Centre Cardiologique du Nord

Saint-Denis, France

Location

Unite de Cardiologie Interventionelle

Toulouse, 4131076, France

Location

Related Publications (1)

• 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.

  PMID: 22994863 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents; Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies; Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Bernard Chevalier, MD

  Centre Cardiologique du Nord, Saint Denis, France

  PRINCIPAL INVESTIGATOR

• Jean Fajadet, MD, PhD

  Unité de Cardiologie Interventionnelle, Toulouse Cedex 3, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 9, 2006
• First Posted: May 10, 2006
• Study Start: March 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: July 29, 2010

Record last verified: 2010-07

Locations

FR (2)