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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01068106
Recruitment Status : Unknown
Verified May 2012 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Active, not recruiting
First Posted : February 12, 2010
Last Update Posted : May 8, 2012
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

Brief 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).

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Device: Nobori® (Biodegradable polymer limus-eluting stents) Device: Xience-V® (Permanent polymer limus-eluting stent) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2010 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Trial of Limus-Eluting Stents With Biodegradable or Permanent Polymer Coatings
Study Start Date : February 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2013

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 Name: Xience-V®

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

Secondary Outcome Measures :
  1. The composite of all cause mortality or myocardial infarction [ Time Frame: 6-8 months ]
  2. Stent thrombosis [ Time Frame: 6-8 months ]
  3. Late luminal loss [ Time Frame: 6-8 months ]
  4. Binary angiographic restenosis [ Time Frame: 6-8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01068106

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Deutsches Herzzentrum Muenchen Identifier: NCT01068106     History of Changes
Other Study ID Numbers: GE IDE No. S03010
First Posted: February 12, 2010    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases