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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: drug-eluting stent

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.

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Cypher™ sirolimus-eluting stent	Device: drug-eluting stent; PCI; Other Names: Cypher™ sirolimus-eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
angiographic in-lesion late loss	6 months post-procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
occurrence of bleeding	1, 6, 9 months and, 2 and 3 years post-procedure

Collaborators and Investigators

• Sponsor: Cordis Corporation
• Investigators: Principal Investigator: Franz-Josef Neumann, MD, Herz-Zentrum Bad Krozingen; Principal Investigator: Walter Desmet, MD, K.U. Leuven

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion (Actual): December 1, 2003
• Study Completion (Actual): August 1, 2006

Study Registration Dates

• First Submitted: October 4, 2005
• First Submitted That Met QC Criteria: October 4, 2005
• First Posted (Estimate): October 5, 2005

Study Record Updates

• Last Update Posted (Estimate): April 30, 2008
• Last Update Submitted That Met QC Criteria: April 29, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: EC01-06