3 Limus Agent Eluting Stents With Different Polymer Coating

Coronary Heart Disease Clinical Trial

— ISAR-TEST-4  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598676
• Other study ID #: GE IDE No. S02607
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2008
• Last updated: March 12, 2010
• Start date: September 2007
• Est. completion date: April 2009

Study information

• Verified date: March 2010
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2600
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Intervention

Device:
• biodegradable polymer Rapamycin-eluting stent
due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted
• permanent polymer rapamycin-eluting stent (Cypher)
due to randomization, rapamycin-eluting stent with permanent polymer will be implanted
• permanent polymer everolimus-eluting stent (Xience, Promus)
due to randomization, everolimus-eluting stent with permanent polymer will be implanted

Locations

Country	Name	City	State
Germany	Medizinische Klinik, Klinikum rechts der Isar	Muenchen
Germany	Deutsches Herzzentrum Muenchen	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Byrne RA, Kastrati A, Kufner S, Massberg S, Birkmeier KA, Laugwitz KL, Schulz S, Pache J, Fusaro M, Seyfarth M, Schömig A, Mehilli J; Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) Investigators. Ran — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 months	No
Secondary	In-segment binary restenosis at follow-up angiography		6-8 months	No
Secondary	Late Lumen Loss at follow-up angiography		6-8 months	No
Secondary	All cause mortality.		12 months	No
Secondary	Incidence of stent thrombosis (by ARC definition)		12 months	Yes