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: currently enrolling (n=200)
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. The study will include a subgroup of patients with long arterial lesions.
This post-CE Mark study is now enrolling. To learn more about this study, visit www.clinicaltrials.gov and search for NCT02802306.TOBA III Site Locator
STATUS: currently enrolling (n=232)
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.
This study received FDA IDE approval in December 2016 and selected sites are now enrolling. To learn more about this study, visit www.clinicaltrials.gov and search for NCT02942966.TOBA II BTK Site Locator
If you are a physician interested in participating in a study, please complete our Medical Information Request Form.
Peripheral Artery Disease (PAD) is a narrowing or blockage of normal blood flow in the leg(s) and/or feet. If left untreated, it can cause significant pain while walking, changes in skin color, pain at rest and in some cases, sores and ulcers. You may qualify for one of these studies if you have leg pain and other risk factors such as smoking, high cholesterol and/or high blood pressure. If you are interested in participating, please use the site locator buttons found in the study descriptions to find a physician investigator near you.
Lutonix® is a registered trademark of BARD Peripheral Vascular.
IN.PACT™ Admiral™ are trademarks of Medtronic, Inc.