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UH Case Medical Center the First in Region to Enroll Patients in Worldwide Study
Date:1/24/2012

an excellent alternative therapy to surgical bypass, especially points of flexion in the leg or at the knee, where placement of a metal stent would possibly lead to ultimate fracture of the stent," said Dr. Parikh.

LEVANT 2 is the largest randomized peripheral drug-coated balloon clinical trial to date, and one of the largest peripheral vascular studies ever conducted. Currently, University Hospitals currently ranks as the highest enrolling site in the region as well as among the top 10 in the world for enrollment. 

Randomized patients in LEVANT 2 will be followed for a total of five years and independent core laboratories will be utilized to verify trial outcomes.  The primary safety endpoint is a composite of freedom from all-cause peri-operative death and freedom at one year from amputation, re-intervention, and death.  The primary efficacy endpoint is primary patency at one year. 

"We believe this trial may lead to a substantially better treatment option for patients with PAD," said Dr. Kashyap, UH Case Medical Center's Division Chief of Vascular Surgery and Professor at Case Western Reserve University School of Medicine "We are very proud of our ability to contribute to this important research and include ourselves in such a prestigious group of investigators around the world."

Drug coated balloons are similar to standard angioplasty balloons except they are coated with an anti-restenotic drug aimed at preventing the artery from becoming blocked again.  During the procedure, the Moxy balloon is inserted inside the narrowed area of the artery and then inflated to open the blockage and deliver the drug to the artery.  After this short inflation, the balloon is removed from the body, leaving nothing but the drug behind in the artery.

LEVANT 2 is a follow-on trial to LEVANT 1, which was a 101-patient multicenter randomized trial.  Patients either received the Moxy balloon or standard angiopl
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SOURCE University Hospitals Case Medical Center
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