Overview

This trial is active, not recruiting.

Condition coronary heart disease
Treatments nobori® (biodegradable polymer limus-eluting stents), xience-v® (permanent polymer limus-eluting stent)
Phase phase 4
Sponsor Deutsches Herzzentrum Muenchen
Start date February 2010
End date September 2012
Trial size 2010 participants
Trial identifier NCT01068106, GE IDE No. S03010

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Biodegradable polymer limus-eluting stents
nobori® (biodegradable polymer limus-eluting stents) Nobori®
due randomization biodegradable polymer limus-eluting stents will be implanted
(Active Comparator)
Permanent polymer limus-eluting stent
xience-v® (permanent polymer limus-eluting stent) Xience-V®
due randomization permanent polymer limus-eluting stent will be implanted

Primary Outcomes

Measure
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 Outcomes

Measure
The composite of all cause mortality or myocardial infarction
time frame: 6-8 months
Stent thrombosis
time frame: 6-8 months
Late luminal loss
time frame: 6-8 months
Binary angiographic restenosis
time frame: 6-8 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Prospective, Randomized Trial of Limus-Eluting Stents With Biodegradable or Permanent Polymer Coatings
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Deutsches Herzzentrum Muenchen.