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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00232856
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : April 30, 2008
Information provided by:
Cordis Corporation

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: drug-eluting stent Phase 4

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  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2002
Actual Primary Completion Date : December 2003
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Cypher™ sirolimus-eluting stent
Device: drug-eluting stent
Other Name: Cypher™ sirolimus-eluting stent

Primary Outcome Measures :
  1. angiographic in-lesion late loss [ Time Frame: 6 months post-procedure ]

Secondary Outcome Measures :
  1. in-stent mean percent diameter stenosis (%DS) [ Time Frame: 6-months post-procedure ]
  2. i-stent late loss (LL) [ Time Frame: 6 months post-procedure ]
  3. in-lesion binary restenosis [ Time Frame: 6-months post-procedure ]
  4. Target Vessel Revascularization (TVR) [ Time Frame: 9-months post-procedure ]
  5. 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 ]
  6. 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 ]
  7. occurrence of bleeding [ Time Frame: 1, 6, 9 months and, 2 and 3 years post-procedure ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00232856

K.U. Leuven
Leuven, Belgium, 3000
Herz-zentrum Bad Krozingen
Bad-Krozingen, Germany, 78189
Sponsors and Collaborators
Cordis Corporation
Principal Investigator: Franz-Josef Neumann, MD Herz-zentrum Bad Krozingen
Principal Investigator: Walter Desmet, MD K.U. Leuven

Responsible Party: Hans-Peter Stoll - Director Medical Affairs, Cordis Identifier: NCT00232856     History of Changes
Other Study ID Numbers: EC01-06
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: April 30, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs