- Tack Endovascular System®
- Clinical Trials
- Peripheral Artery Disease
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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.
Intact Vascular is advancing clinical science to improve the treatment of peripheral artery disease and critical limb ischemia following POBA and/or DCB angioplasty. Investigators currently are conducting these clinical trials to study the use of the Tack Endovascular System® in new applications.
You may qualify for this study if you have leg pain and other risk factors such as smoking, high cholesterol and/or high blood pressure. If you are a physician interested in participating in a study, please complete our Medical Information Request Form. If you are a patient interested in finding a study near you, please use the Site Locator buttons below.
Tack Optimized Balloon Angioplasty II
Enrollment Complete; In Follow-Up
This multi-center, U.S. and European study is designed to evaluate the safety and effectiveness of the Tack Endovascular System® in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) using standard and drug-coated balloon angioplasty (BARD Lutonix®) of the superficial femoral and proximal popliteal artery(ies).
This study received FDA approval in August 2015 and subject enrollment is complete. This study is no longer enrolling. To learn more about this study, visit www.clinicaltrials.gov and search for NCT02522884.
Tack Optimized Balloon Angioplasty III
This multi-center, single-arm European study is designed to investigate the safety and efficacy of the Tack Endovascular System® in combination with the Medtronic IN.PACT® Admiral® drug-coated angioplasty balloon in the treatment of Peripheral Arterial Disease (PAD) in the superficial femoral and proximal popliteal arteries. The study will include a subgroup of patients with long arterial lesions.
This post-CE Mark study is now enrolling. To learn more about this study, visit www.clinicaltrials.gov and search for NCT02802306.
Tack Optimized Balloon Angioplasty II Below the Knee
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 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.
This study received FDA approval in December 2016 and selected sites are now enrolling. To learn more about this study, visit www.clinicaltrials.gov and search for NCT02942966.