Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries (TOBA II BTK)
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|ClinicalTrials.gov Identifier: NCT02942966|
Recruitment Status : Completed
First Posted : October 24, 2016
Results First Posted : July 28, 2021
Last Update Posted : January 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: Tack Endovascular System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||233 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tack Optimized Balloon Angioplasty Study for the Below The Knee Arteries Using the Tack Endovascular System®|
|Actual Study Start Date :||February 8, 2017|
|Actual Primary Completion Date :||July 11, 2019|
|Actual Study Completion Date :||January 10, 2022|
Experimental: Tack Implant
Implantation of a Tack using the Intact Vascular Tack Endovascular System for the repair of post angioplasty dissections below the knee.
Device: Tack Endovascular System
Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System.
- Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days [ Time Frame: 6 months ]Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days.
- Safety - Number of Participants With MALE Plus POD at 30 Days [ Time Frame: 30 days ]Major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death at 30 days
- Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months [ Time Frame: 6 months ]Target lesion(s) tacked segment(s) patency at 6 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 6 month follow-up visit window, it should be used in place of the duplex ultrasound. Evidence of no blood flow within the Tacked segment indicates restenosis/loss of patency.
- Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months [ Time Frame: 6 months ]Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months.
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): NCT02942966
|Principal Investigator:||Patrick J. Geraghty, MD||Washington University School of Medicine in St. Louis|
|Principal Investigator:||George Adams, MD||Rex Hospital|