Infrapopliteal dissection repair using the Tack Endovascular System following plain balloon angioplasty (POBA)

233

Subjects Enrolled at 41 US, European and New Zealand sites

Endpoints Safety: MALE + POD at 30 days
Efficacy: 6-Month MALE + POD at 30 days

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 and search for NCT02942966.

233

Subjects Enrolled at 41 US, European and New Zealand sites

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 and search for NCT01663818.