A Study of the Cypher SES to Treat Restenotic Native Coronary Artery Lesions. - Full Text View

Sponsored by:	Cordis Corporation
Information provided by:	Cordis Corporation
ClinicalTrials.gov Identifier:	NCT00232856

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Device: drug-eluting stent	Phase IV

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Non-Randomised Study of the CYPHER™ Sirolimus-Eluting Stent in the Treatment of Patient With an in-Stent Restenotic Native Coronary Artery Lesion

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:

angiographic in-lesion late loss [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

in-stent mean percent diameter stenosis (%DS) [ Time Frame: 6-months post-procedure ] [ Designated as safety issue: Yes ]
i-stent late loss (LL) [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: Yes ]
in-lesion binary restenosis [ Time Frame: 6-months post-procedure ] [ Designated as safety issue: Yes ]
Target Vessel Revascularization (TVR) [ Time Frame: 9-months post-procedure ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 9 months post-procedure ] [ Designated as safety issue: Yes ]
Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization in-hospital [ Time Frame: 1, 6, 9 months and, 2 and 3 years post-procedure ] [ Designated as safety issue: Yes ]
occurrence of bleeding [ Time Frame: 1, 6, 9 months and, 2 and 3 years post-procedure ] [ Designated as safety issue: Yes ]

Enrollment:	162
Study Start Date:	December 2002
Study Completion Date:	August 2006
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Cypher™ sirolimus-eluting stent	Device: drug-eluting stent PCI

Detailed Description:

This is a multicenter (11 sites), non-randomized study. Patients who meet the eligibility criteria will be treated with the Cypher™ sirolimus-eluting stent. All patients will have a repeat angiography at six months post-procedure and will be additionally followed clinically at 1, 6 and 9 months and up to 3 years. The results of this study will be compared with the outcome of the GAMMA I / II as the historical control.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232856

Locations

Belgium
K.U. Leuven
Leuven, Belgium, 3000
Germany
Herz-zentrum Bad Krozingen
Bad-Krozingen, Germany, 78189

Sponsors and Collaborators

Cordis Corporation

Investigators

Principal Investigator:	Franz-Josef Neumann, MD	Herz-zentrum Bad Krozingen
Principal Investigator:	Walter Desmet, MD	K.U. Leuven

More Information

Responsible Party:	Cordis ( Hans-Peter Stoll - Director Medical Affairs )
Study ID Numbers:	EC01-06
Study First Received:	October 4, 2005
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00232856
Health Authority:	Belgium: Institutional Review Board; Netherlands: Independent Ethics Committee; Germany: Ethics Commission; Italy: Ethics Committee

Study placed in the following topic categories:

Sirolimus
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009