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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01068106
First received: February 11, 2010
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Coronary Heart Disease
 Device: Nobori® (Biodegradable polymer limus-eluting stents)
Device: Xience-V® (Permanent polymer limus-eluting stent)
 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: Prospective, Randomized Trial of Limus-Eluting Stents With Biodegradable or Permanent Polymer Coatings

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • A composite endpoint of cardiac death, myocardial infarction related to the target vessel or revascularisation related to the target lesion. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The composite of all cause mortality or myocardial infarction [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]
  • Late luminal loss [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
  • Binary angiographic restenosis [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2010
Study Start Date: February 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Xience-V®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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% 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068106

Locations
Germany
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Klinikum rechts der Isar der Technischen Universitaet Muenchen
Munich, Germany, 81675
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Study Chair: Julinda Mehilli, MD Deutsches Herzzentrum Muenchen
  More Information

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01068106     History of Changes
Other Study ID Numbers: GE IDE No. S03010
Study First Received: February 11, 2010
Last Updated: May 7, 2012
Health Authority: Germany: German Institute of Medical Documentation and Information

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 13, 2013