Intact Vascular is advancing clinical science to improve the treatment of peripheral artery disease (PAD) and critical limb ischemia (CLI) following standard and drug-coated balloon angioplasty. Investigators are currently conducting these clinical trials to study the use of the Tack Endovascular System® in new applications.STATUS: In follow up, enrollment complete (N=201)
DESCRIPTION: This multi-center, single-arm European study is designed to investigate the safety and efficacy of the Tack Endovascular System® for the repair of dissection(s) type(s) A through F resulting from post percutaneous transluminal angioplasty (PTA) using the Medtronic IN.PACT™ Admiral™ drug-coated angioplasty balloon in the superficial femoral and proximal popliteal arteries. This study includes a subgroup of patients with long arterial lesions.
To learn more about this study, visit www.clinicaltrials.gov.STATUS: In follow up, enrollment complete (N=233)
DESCRIPTION: This multi-center, global study is the first IDE clinical trial approved in the United States to investigate the safety and effectiveness of a permanent vascular implant in arteries below the knee. TOBA II BTK will evaluate the Tack Endovascular System® in subjects with peripheral arterial disease (PAD) and dissections resulting from percutaneous transluminal angioplasty (PTA) using a standard balloon in the mid/distal popliteal, tibial and/peroneal arteries.
To learn more about this study, visit www.clinicaltrials.gov.
Lutonix® is a registered trademark of BD Interventional.
IN.PACT® and Admiral® are registered trademarks of Medtronic, Inc.