Test Efficacy of Biodegradable and Permanent Limus-Eluting Stents

NCT01068106 | Unknown Phase 4 DMC

• 1 other identifier: GE IDE No. S03010
• Study Type: interventional
• Target: 2,010
• Locations: 1 country
• Sites: 2

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).

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• A composite endpoint of cardiac death, myocardial infarction related to the target vessel or revascularisation related to the target lesion.

  12 months

Secondary Outcomes (4)

• 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

Study Arms (2)

BPLES

ACTIVE COMPARATOR

Biodegradable polymer limus-eluting stents

Device: Nobori® (Biodegradable polymer limus-eluting stents)

PPLES

ACTIVE COMPARATOR

Permanent polymer limus-eluting stent

Device: Xience-V® (Permanent polymer limus-eluting stent)

Interventions

Nobori® (Biodegradable polymer limus-eluting stents) DEVICE

due randomization biodegradable polymer limus-eluting stents will be implanted

Also known as: Nobori®, ISAR G2

BPLES

Xience-V® (Permanent polymer limus-eluting stent) DEVICE

due randomization permanent polymer limus-eluting stent will be implanted

Also known as: Xience-V®

PPLES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Sites (2)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

Klinikum rechts der Isar der Technischen Universitaet Muenchen

Munich, 81675, Germany

Location

Related Publications (1)

• 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.

  PMID: 24579987 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Julinda Mehilli, MD

  Deutsches Herzzentrum Muenchen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2010
• First Posted: February 12, 2010
• Study Start: February 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2013
• Last Updated: May 8, 2012

Record last verified: 2012-05

Locations

DE (2)