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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00232856
First received: October 4, 2005
Last updated: April 29, 2008
Last verified: April 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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
Other Name: Cypher™ sirolimus-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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

ClinicalTrials.gov processed this record on August 18, 2014