None listed
Conditions
Brief summary
This study was originally planned to enroll 600 patients in a proscpective evaluation of a new stent developed for use in a special class of coronary artery blockages located at bifurcations. Bifurcations are lesions that occur just at the point where 1 vessel splits into two. Bifurcation lesions have been shown in the past to be difficult to treat with conventional stents and techniques. The study device is desigined specifically for these types of lesions. The study is designed to show that use of the new stent results in lower clinical event rates compared to a historical control group. Follow up will occur frequently in the first year (1, 6, 9 and 12 months), then annually for 5 years. The study was modified to only include enrollment for the 300 subjects planned in Europe, Australia, and New Zealand. The 300 subjects that were planned for enrollment in the United States will instead be enrolled under a randomized trial as (newly) required by the US FDA.
Interventions
This study was originally designed to enroll 600 patients with de novo bifurcation lesions in native coronary arteries. The treatment will be single session stent implant with the Biolimus eluting Axxess stent system. Clinical follow up take place at 1, 6, 9 months, and annually for 5 years. Data will be compared to historical data set derived from the literature for patients treated with metal stents.
The study was modified to only enroll outside of the United States, therefore enrollment was
This study was originally designed to enroll 600 patients with de novo bifurcation lesions in native coronary arteries. The treatment will be single session stent implant with the Biolimus eluting Axxess stent system. Clinical follow up take place at 1, 6, 9 months, and annually for 5 years. Data will be compared to historical data set derived from the literature for patients treated with metal stents. The study was modified to only enroll outside of the United States, therefore enrollment was limited to 300 study subjects. (The original study plan called for 300 OUS and 300 US.)
Sponsors
Devax, Inc
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Suitable candidate for percutaneous transluminal coronary angioplasty (PTCA) and/or stentingLesion matches Duke University angiographic criteria for a bifurcaiton.
Exclusion criteria
Pregnant or women of childbearing potentialConcurrent MIDisease in more than two coronary arteriesRenal dysfunctionPrior stenting to target vesselUnable to comply with follow up procedure.
Outcome results
None listed