Femoropopliteal dissection repair using the Tack Endovascular System following IN.PACT Admiral drug-coated balloon angioplasty

97.7%

Dissection Resolution

97.5%

12m K-M Freedom
from CD-TLR

95.0%

12m K-M
Primary Patency

0.6%

Bail Out Stent Rate

CONCLUSION:

High patency rate and high freedom from CD-TLR position Tack to be a clinically important treatment option for focal dissection repair after balloon angioplasty.

STATUS: In follow up, enrollment complete (N=201). 169 patients with lesions ≤150mm and 32 patients with lesions >150mm and ≤250mm.

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. 169 patients were enrolled with lesions ≤150mm and powered to meet primary endpoints (key results above). An additional 32 patients with lesions >150 and ≤250mm were enrolled and analyzed separately for observation:

• 98.8 Dissection resolution
• 89.3% K-M Patency at 12 months
• 96.8% K-M Freedom from CD-TLR at 12 months
• 0.0% Bail out stent rate
There were a total of 201 patients enrolled at 14 European sites and twelve-month follow up has been completed. This study is in the follow-up phase.

Twelve-month results were presented in San Francisco, California at the TCT 2019 Conference by Dr. Marianne Brodmann.

To learn more about this study, visit www.clinicaltrials.gov and search for NCT02802306.
IN.PACT and Admiral are trademarks of Medtronic, Inc.

97.7%

Dissection Resolution

95.0%

12m K-M
Primary Patency

97.5%

12m K-M Freedom
from CD-TLR

0.6%

Bail Out Stent Rate

CONCLUSION:

High patency rate and high freedom from CD-TLR position Tack to be a clinically important treatment option for focal dissection repair after balloon angioplasty.

STATUS: In follow up, enrollment complete (N=201). 169 patients with lesions ≤150mm and 32 patients with lesions >150mm and ≤250mm.

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. 169 patients were enrolled with lesions ≤150mm and powered to meet primary endpoints (key results above). An additional 32 patients with lesions >150 and ≤250mm were enrolled and analyzed separately for observation:

• 98.8 Dissection resolution
• 89.3% K-M Patency at 12 months
• 96.8% K-M Freedom from CD-TLR at 12 months
• 0.0% Bail out stent rate
There were a total of 201 patients enrolled at 14 European sites and twelve-month follow up has been completed. This study is in the follow-up phase.

Twelve-month results were presented in San Francisco, California at the TCT 2019 Conference by Dr. Marianne Brodmann.

To learn more about this study, visit www.clinicaltrials.gov and search for NCT02802306.
IN.PACT and Admiral are registered trademarks of Medtronic, Inc.