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

Coronary Artery Disease Clinical Trial

— TROPICAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232856
• Other study ID #: EC01-06
• Status: Completed
• Phase: Phase 4
• First received: October 4, 2005
• Last updated: April 29, 2008
• Start date: December 2002
• Est. completion date: August 2006

Study information

• Verified date: April 2008
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardNetherlands: Independent Ethics CommitteeGermany: Ethics CommissionItaly: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: August 2006
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. 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:

1. Unprotected left main coronary disease with = 50% stenosis;

2. Patient previously treated with brachytherapy in any coronary vessel.

3. Target lesion involves bifurcation including a side branch >2.5mm in diameter.

4. 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• drug-eluting stent
PCI

Locations

Country	Name	City	State
Belgium	K.U. Leuven	Leuven
Germany	Herz-zentrum Bad Krozingen	Bad-Krozingen

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	angiographic in-lesion late loss		6 months post-procedure	Yes
Secondary	in-stent mean percent diameter stenosis (%DS)		6-months post-procedure	Yes
Secondary	i-stent late loss (LL)		6 months post-procedure	Yes
Secondary	in-lesion binary restenosis		6-months post-procedure	Yes
Secondary	Target Vessel Revascularization (TVR)		9-months post-procedure	Yes
Secondary	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	Yes
Secondary	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		1, 6, 9 months and, 2 and 3 years post-procedure	Yes
Secondary	occurrence of bleeding		1, 6, 9 months and, 2 and 3 years post-procedure	Yes