3 Limus Agent Eluting Stents With Different Polymer Coating (ISAR-TEST-4)
This study has been completed.
Sponsor:
Deutsches Herzzentrum Muenchen
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00598676
First received: January 10, 2008
Last updated: March 12, 2010
Last verified: March 2010
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Purpose
The aim of this study is to determine whether biodegradable polymer based rapamycin-eluting stent performs equal to permanent polymer based everolimus- and rapamycin-eluting stents regarding reduction of adverse cardiac events at one year.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Heart Disease |
Device: biodegradable polymer Rapamycin-eluting stent Device: permanent polymer rapamycin-eluting stent (Cypher) Device: permanent polymer everolimus-eluting stent (Xience, Promus) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting STents (ISAR-TEST 4): Prospective, Randomized Trial of 3-limus Agent-eluting Stents With Different Polymer Coatings |
Resource links provided by NLM:
Further study details as provided by Deutsches Herzzentrum Muenchen:
Primary Outcome Measures:
- The primary end point of the study is a combined endpoint of cardiac death, myocardial infarction related to the target vessel or revascularization related to the target lesion. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- In-segment binary restenosis at follow-up angiography [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
- Late Lumen Loss at follow-up angiography [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
- All cause mortality. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Incidence of stent thrombosis (by ARC definition) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 2600 |
| Study Start Date: | September 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BPRES
biodegradable polymer rapamycin-eluting stent
|
Device: biodegradable polymer Rapamycin-eluting stent
due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted
Other Name: ISAR stent
|
|
Active Comparator: PPRES
permanent polymer rapamycin-eluting stent
|
Device: permanent polymer rapamycin-eluting stent (Cypher)
due to randomization, rapamycin-eluting stent with permanent polymer will be implanted
Other Name: Cypher
|
|
Active Comparator: PPEES
permanent polymer everolimus-eluting stent
|
Device: permanent polymer everolimus-eluting stent (Xience, Promus)
due to randomization, everolimus-eluting stent with permanent polymer will be implanted
Other Names:
|
Detailed Description:
Drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare metal stents. Although this applies to the vast majority of patients, intimal hyperplasia and in-stent restenosis have not been completely eliminated and remain to occur in certain high risk subgroups. Thus there is ongoing research for new, potentially more effective and safe drug-eluting stent systems.
One direction of extensive research is the search of new polymers such as biodegradable polymers which allow a controlled drug-release and disappear with time, reducing the probability of polymer-induced chronic inflammation on the vessel wall.
Another direction is finding new drugs to suppress neointimal hyperplasia. Promising preclinical and clinical results suggest that the Everolimus eluting stent platform might provide potential improvements over prior generations of drug-eluting stents.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in native coronary vessels.
- Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
- In women with childbearing potential a negative pregnancy test is mandatory
Exclusion Criteria:
- Target lesion located in the left main trunk.
- Target lesion located in the bypass graft.
- In-stent restenosis.
- Cardiogenic shock.
- Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
- Known allergy to the study medications: Clopidogrel, Rapamycin, Everolimus, stainless steel or cobalt chrome.
- Inability to take clopidogrel for at least 6 months.
- Pregnancy (present, suspected or planned) or positive pregnancy test.
- Previous enrollment in this trial.
- Patient's inability to fully cooperate with the study protocol
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: NCT00598676
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598676
Locations
| Germany | |
| Medizinische Klinik, Klinikum rechts der Isar | |
| Muenchen, Germany, 81675 | |
| Deutsches Herzzentrum Muenchen | |
| Munich, Germany, 80636 | |
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
| Study Chair: | Albert Schoemig, MD | Deutsches Herzzentrum Muenchen |
| Principal Investigator: | Adnan Kastrati, MD | Deutsches Herzzentrum Muenchen |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof. A. Schömig, Deutsches Herzzentrum Munich |
| ClinicalTrials.gov Identifier: | NCT00598676 History of Changes |
| Other Study ID Numbers: | GE IDE No. S02607 |
| Study First Received: | January 10, 2008 |
| Last Updated: | March 12, 2010 |
| Health Authority: | Germany: German Institute of Medical Documentation and Information |
Additional relevant MeSH terms:
|
Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Everolimus |
Sirolimus Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents |
ClinicalTrials.gov processed this record on September 28, 2016