CLINICAL STUDIES

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.

Click on any of the TOBA trials to learn more.

TOBA II BTK

This multi-center, global pivotal study evaluates the Tack Endovascular System® (4F, 1.5-4.5mm) 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.

TOBA II Clinical Studies

TOBA II is designed to investigate the safety and efficacy of the Tack Endovascular System® (6F, 3.5-6.0mm) in patients with post-PTA dissection following POBA or Lutonix® DCB angioplasty in the SFA and proximal popliteal arteries.

92.1%

Dissection Resolution

86.5%

12m K-M Freedom from CD-TLR

79.3%

12m K-M Primary Patency

0.5%

Bail Out Stent Rate

TOBA III Clinical Studies

TOBA III is a European multi-center post-CE Mark study that continues the evaluation of dissection repair with the Tack Endovascular System® (6F, 3.5-6.0mm) following DCB angioplasty with the IN.PACT™ Admiral™ in the SFA and proximal popliteal arteries.

Lutonix® is a registered trademark of BD Interventional.
IN.PACT and Admiral are trademarks of Medtronic, Inc.

97.7%

Dissection Resolution

97.5%

12m K-M Freedom from CD-TLR

95.1%

12m K-M Primary Patency

0.6%

Bail Out Stent Rate

PURPOSEBUILT. PRECISION REPAIR. PRESERVES OPTIONS.

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