Test Efficacy of Biodegradable and Permanent Limus-Eluting Stents (ISAR-TEST6)

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

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).

Study Overview

• Status: Unknown
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Device: Nobori® (Biodegradable polymer limus-eluting stents); Device: Xience-V® (Permanent polymer limus-eluting stent)

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 2010
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 80636
    • Deutsches Herzzentrum Muenchen
  • Munich, Germany, 81675
    • Klinikum Rechts der Isar der Technischen Universitaet Muenchen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BPLES; Biodegradable polymer limus-eluting stents	Device: Nobori® (Biodegradable polymer limus-eluting stents); due randomization biodegradable polymer limus-eluting stents will be implanted; Other Names: Nobori®; ISAR G2
Active Comparator: PPLES; Permanent polymer limus-eluting stent	Device: Xience-V® (Permanent polymer limus-eluting stent); due randomization permanent polymer limus-eluting stent will be implanted; Other Names: Xience-V®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
A composite endpoint of cardiac death, myocardial infarction related to the target vessel or revascularisation related to the target lesion.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The composite of all cause mortality or myocardial infarction	6-8 months
Stent thrombosis	6-8 months
Late luminal loss	6-8 months
Binary angiographic restenosis	6-8 months

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Investigators: Study Chair: Julinda Mehilli, MD, Deutsches Herzzentrum Muenchen

Publications and helpful links

General Publications

• Piccolo R, Nicolino A, Danzi GB. The Nobori biolimus-eluting stent: update of available evidence. Expert Rev Med Devices. 2014 May;11(3):275-82. doi: 10.1586/17434440.2014.894458. Epub 2014 Mar 3.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: February 11, 2010
• First Submitted That Met QC Criteria: February 11, 2010
• First Posted (Estimate): February 12, 2010

Study Record Updates

• Last Update Posted (Estimate): May 8, 2012
• Last Update Submitted That Met QC Criteria: May 7, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: GE IDE No. S03010