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: This study has met its primary endpoints, and patients are in follow-up phase.

DESCRIPTION: TOBA II BTK is a multi-center, global pivotal study and the first IDE clinical trial approved in the United States to investigate the safety and effectiveness of a permanent vascular implant as a treatment for post-angioplasty dissections in arteries below the knee (BTK). TOBA II BTK evaluates the Tack Endovascular System (4F) in patients with critical limb ischemia (CLI) and dissections resulting from percutaneous transluminal angioplasty (PTA) using a standard balloon in the mid/distal popliteal, tibial and/peroneal arteries.

There were a total of 233 subjects enrolled at 41 sites in US, Europe and New Zealand.

Six-month results were presented in Las Vegas, Nevada at the VIVA 2019 Conference by Dr. George Adams.

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: This study has met its primary endpoints, and patients are in follow-up phase.

DESCRIPTION: TOBA II BTK is a multi-center, global pivotal study and the first IDE clinical trial approved in the United States to investigate the safety and effectiveness of a permanent vascular implant as a treatment for post-angioplasty dissections in arteries below the knee (BTK). TOBA II BTK evaluates the Tack Endovascular System (4F) in patients with critical limb ischemia (CLI) and dissections resulting from percutaneous transluminal angioplasty (PTA) using a standard balloon in the mid/distal popliteal, tibial and/peroneal arteries.

There were a total of 233 subjects enrolled at 41 sites in US, Europe and New Zealand.

Six-month results were presented in Las Vegas, Nevada at the VIVA 2019 Conference by Dr. George Adams.

To learn more about this study, visit www.clinicaltrials.gov and search for NCT02942966.

CAUTION: Investigational Device. Tack Endovascular System (4F) is limited by federal (United States) law to investigational use. Not available for sale in the United States.