NCT02299011

Comparison of Biomatrix and Orsiro Drug Eluting Stent

Comparison of Biomatrix and Orsiro Drug Eluting Stent in Angiographic Result in Patients With All-comer Patients With Coronary Artery Disease : A Multicenter, Randomized, Open Label Study (BIODEGRADE Study)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,341 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the BIODEGRADE study is to evaluate clinical efficacy of the Orsiro drug-eluting stent compared with Biomatrix drug-eluting stent, both of which have biodegradable polymer for the treatment of all-comers' coronary artery diseases.

Detailed description

The rate of in-stent restenosis after percutaneous coronary intervention (PCI) has decreased since the launching of drug-eluting stents (DES). However, restenosis still remains a problem since PCI is being performed on more complex, calcified, tortuous and tough lesions. Furthermore, there is still a controversy on whether these DES are more thrombogenic than bare metal stent (BMS) because of inflammation related to the polymer coating and delayed vessel healing due to the eluted drug despite of reduced restenosis. Therefore, works aiming to reduce both restenosis and thrombotic event are still on-going in the field of interventional cardiology, and there has been a rush of various third generation DES with "biodegradable polymer". Recently, Orsiro hybrid DES (Biotronik AG, Bulach, Switzeland) has been developed. The Orsiro DES incorporated optimally combined two kind of polymer onto thinner cobalt-chromium backbone (60um) compared with earlier type of DES. The BIOlute® active component is a bioabsorbable polymer matrix combined with an anti-proliferative drug, sirolimus, that is released in a controlled manner leaving only the PROBIO® coated stent in the long-term. The PROBIO® passive coating encapsulates the stent and eliminates interaction between the metal stent and the surrounding tissue. To date, Orsiro stent showed excellent results in terms of late lumen loss at 9 months in first-in-man single arm trial comparing the historical results of other DES (BIOFLOW-I trial), and RCT with non-inferiority design, comparing late lumen loss at 9 months of Orsiro versus everolimus-eluting stent (Xience prime®) is ongoing (BIOFLOW-II trial). However, there have been no trials comparing the Orsiro stent versus the Biomatrix stent (Biosensors Inc, Newport Beach, CA, USA). This multicenter, randomized, open label, parallel arm study will evaluate whether the innovative newer generation stent, Orsiro hybrid DES, is non-inferior to the third generation stent, Biomatrix stent, in terms of 18 months late lumen loss.

Conditions

• Coronary Artery Disease
• Myocardial Ischemia

Interventions

Type	Name	Description
DEVICE	Orsiro drug eluting stent	Orsiro Hybrid drug eluting stent
DRUG	Biomatrix drug eluting stent	Biomatrix Flex drug eluting stent

Timeline

• Start date: 2014-07-01
• Primary completion: 2019-06-01
• Completion: 2019-09-01
• First posted: 2014-11-24
• Last updated: 2019-09-25

Locations

1 site across 1 country: South Korea