A Study of the Cypher SES to Treat Restenotic Native Coronary Artery Lesions.

NCT00232856 | Completed Phase 4 DMC

• 1 other identifier: EC01-06
• Study Type: interventional
• Target: 162
• Locations: 2 countries
• Sites: 2

Brief Summary

The main objective of this study is to assess the safety and effectiveness of the Cypher™ sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an in-stent restenotic native coronary artery lesion.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• angiographic in-lesion late loss

  6 months post-procedure

Secondary Outcomes (7)

• in-stent mean percent diameter stenosis (%DS)

  6-months post-procedure

• i-stent late loss (LL)

  6 months post-procedure

• in-lesion binary restenosis

  6-months post-procedure

• Target Vessel Revascularization (TVR)

  9-months post-procedure

• Target Vessel Failure (TVF) defined as any revascularization of the index vessel or myocardial infarction or death that cannot be clearly attributed to a vessel other than the index vessel

  9 months post-procedure

Study Arms (1)

1

OTHER

Cypher™ sirolimus-eluting stent

Device: drug-eluting stent

Interventions

drug-eluting stent DEVICE

PCI

Also known as: Cypher™ sirolimus-eluting stent

1

Eligibility Criteria

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

You may qualify if:

• The patient has an in-stent restenosis of ≥ 60% and \< 100% (by QCA online of the MLD compared to the distal reference diameter) in a native coronary artery.
• The 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.

You may not qualify if:

• Unprotected left main coronary disease with ≥ 50% stenosis;
• Patient previously treated with brachytherapy in any coronary vessel.
• Target lesion involves bifurcation including a side branch \>2.5mm in diameter.
• The patient sustained a recent (\<72 hours) myocardial infarction defined as a serum CK 2x the upper limit of normal and elevated MB or abnormal lab values.

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (2)

K.U. Leuven

Leuven, 3000, Belgium

Location

Herz-zentrum Bad Krozingen

Bad Krozingen, 78189, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

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

Study Officials

• Franz-Josef Neumann, MD

  Herz-zentrum Bad Krozingen

  PRINCIPAL INVESTIGATOR

• Walter Desmet, MD

  K.U. Leuven

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 5, 2005
• Study Start: December 1, 2002
• Primary Completion: December 1, 2003
• Study Completion: August 1, 2006
• Last Updated: April 30, 2008

Record last verified: 2008-04

Locations

BE (1); DE (1)