link to Video of Tack Endovascular System

This animation is provided for general information only. It is not intended to provide clinical instructions for use (IFU). Always read and understand the IFU supplied with the device prior to use.

Completed enrollment

Intact Vascular and its investigators have completed enrollment in three separate studies of the Tack Endovascular System®. Here is a summary of the findings:


1

Tack Optimized Balloon Angioplasty (TOBA) Study for Femoropopliteal Arteries Using the Tack Endovascular System®

This multi-center, post-CE mark study evaluated the performance of the Tack Endovascular System® in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty PTA of superficial femoral or popliteal artery(ies). There were 138 patients enrolled and 12-month follow up has been completed. The results were presented by Dr. Bosiers in a presentation entitled Tack Optimized Balloon Angioplasty: TOBA Trial 12-Month Results at the LINC conference in Leipzig, Germany on January 27, 2015.

The study is ongoing, but no longer recruiting participants. The positive results supported Intact Vascular’s decision to conduct an Investigational Study Exemption, called TOBA II, which currently is enrolling subjects in the U.S. and Europe. For more information on the presentation and key findings, click here.     

2

Prospective, Multi-center Tack Optimized Balloon Angioplasty Below the Knee (TOBA BTK) Study for Infrapopliteal Arteries Using the Tack Endovascular System®

This is a multi-center, study to evaluate the safety and effectiveness of the 4F Tack Endovascular System in treating dissections that occur following Below the Knee (BTK) balloon angioplasty. This study focused on peripheral arteries with Reference Vessel Diameters (RVD) ranging from 1.5mm to 4.5mm. Enrollment has been completed and patients are being followed.  Positive six-month results were presented by Dr. Brodmann at LINC 2016 and positive 12-month results were presented by Dr. Wissgott at SCAI 2016. Click here to read more about the findings. 

3

Safety and Feasibility Study of the Tack Intravascular Staple System (Tack) for Securing Vascular Flaps Resulting from Balloon Angioplasty in the Infrainguinal Artery(ies)

This study evaluated the safety and feasibility of using the Tack Endovascular System® in patients with vascular flaps in the infrainguinal arteries following angioplasty dissection. The data demonstrated that the system was safe.


If you are interested in a clinical study or want more information about presentations and publications, please contact info@intactvascular.com