Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries (TOBA II)
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|ClinicalTrials.gov Identifier: NCT02522884|
Recruitment Status : Completed
First Posted : August 13, 2015
Results First Posted : December 10, 2019
Last Update Posted : April 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Artery Disease||Device: Tack Endovascular System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||213 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tack Optimized Balloon Angioplasty Study for Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||May 2018|
|Actual Study Completion Date :||March 2020|
Experimental: Tack Implant
Implantation of a Tack using the Intact Vascular Tack Endovascular System for the repair of post angioplasty dissections.
Device: Tack Endovascular System
Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System.
- Efficacy - Number of Subjects That Met Primary Patency Criteria at 12 Months [ Time Frame: 12 Months ]Primary patency defined as freedom from Clinical Events Committee (CEC) adjudicated clinically-driven target lesion revascularization (CD-TLR) and freedom from core lab adjudicated duplex ultrasound derived binary restenosis at 12 months (defined as peak systolic velocity ratio (PSVR) >2.5)
- Safety - Number of Subjects That Met the Primary Safety Criteria of Freedom From Major Adverse Events at 30 Days [ Time Frame: 30 Days ]Freedom from the occurrence of any new-onset major adverse event(s) (MAEs) defined as index limb amputation (above the ankle), CEC adjudicated clinically-driven target lesion revascularization (CD-TLR), or all-cause death at 30 days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522884
|Principal Investigator:||William A. Gray, MD||Main Line Health/Lankenau Heart Institute|