Test Efficacy of Biodegradable and Permanent Limus-Eluting Stents

Coronary Heart Disease Clinical Trial

— ISAR-TEST6  

Official title:

Prospective, Randomized Trial of Limus-Eluting Stents With Biodegradable or Permanent Polymer Coatings

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01068106
• Other study ID #: GE IDE No. S03010
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 11, 2010
• Last updated: May 7, 2012
• Start date: February 2010
• Est. completion date: September 2013

Study information

• Verified date: May 2012
• 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 prospective, randomized study is to compare the efficacy and safety of biodegradable polymer based limus-eluting stents (BPDES) with permanent polymer based everolimus eluting stents (PPDES).

Description:

Restenosis affects 20-40% of de novo coronary lesions treated with bare-metal stents. Although it is often considered a benign process, recent data indicate that in-stent restenosis has a negative impact on long-term survival of patients treated with coronary stents. Drug eluting stents have emerged as the most effective strategy for the prevention of restenosis. A large number of studies showed that drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare-metal stents. Available evidence shows that all 3 limus drugs − rapamycin, everolimus and biolimus − are very effective in suppressing neointima formation after coronary stenting. Drugs are fully released within a few weeks from the majority of current DES. However, most of the DES use permanent polymers, which continue to remain in the vessel wall even after accomplishing their drug-release mission. Their permanent presence may be associated with persistent inflammatory reaction and delayed neointimal proliferation and vessel thrombosis. Clinical trial evidence with biodegradable polymer DES is still limited, but there are great expectations that this DES technology might be the dominant one in the years to come.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2010
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• 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% 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.

• In-stent restenosis of DES.

• 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: rapamycin, everolimus, biolimus, stainless steel or cobalt chrome.

• Inability to take dual antiplatelet therapy 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:
• Nobori® (Biodegradable polymer limus-eluting stents)
due randomization biodegradable polymer limus-eluting stents will be implanted
• Xience-V® (Permanent polymer limus-eluting stent)
due randomization permanent polymer limus-eluting stent will be implanted

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Muenchen	Munich
Germany	Klinikum rechts der Isar der Technischen Universitaet Muenchen	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite endpoint of cardiac death, myocardial infarction related to the target vessel or revascularisation related to the target lesion.		12 months	Yes
Secondary	The composite of all cause mortality or myocardial infarction		6-8 months	Yes
Secondary	Stent thrombosis		6-8 months	Yes
Secondary	Late luminal loss		6-8 months	No
Secondary	Binary angiographic restenosis		6-8 months	No