Test Efficacy of Biodegradable and Permanent Limus-Eluting Stents

NCT ID: NCT01068106

Last Updated: 2012-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 2010 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-09-30

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).

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.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BPLES

Biodegradable polymer limus-eluting stents

Group Type: ACTIVE_COMPARATOR

Nobori® (Biodegradable polymer limus-eluting stents)

Intervention Type: DEVICE

due randomization biodegradable polymer limus-eluting stents will be implanted

PPLES

Permanent polymer limus-eluting stent

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

due randomization permanent polymer limus-eluting stent will be implanted

Interventions

Nobori® (Biodegradable polymer limus-eluting stents)

due randomization biodegradable polymer limus-eluting stents will be implanted

Intervention Type: DEVICE

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

due randomization permanent polymer limus-eluting stent will be implanted

Intervention Type: DEVICE

Other Intervention Names

Nobori®; ISAR G2; Xience-V®

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julinda Mehilli, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum Muenchen

Locations

Deutsches Herzzentrum Muenchen

Munich, , Germany

Klinikum rechts der Isar der Technischen Universitaet Muenchen

Munich, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 24579987 (View on PubMed)

Other Identifiers

GE IDE No. S03010

Identifier Type: -

Identifier Source: org_study_id