Tack Optimized Drug Coated Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries (TOBA III)
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|ClinicalTrials.gov Identifier: NCT02802306|
Recruitment Status : Active, not recruiting
First Posted : June 16, 2016
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: Tack Endovascular System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tack Optimized Drug Coated Balloon Angioplasty in the Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||November 2020|
Experimental: Tack Implant
Implantation of a Tack implant using the Intact Vascular Tack Endovascular System for the repair of post DCB-angioplasty dissections.
Device: Tack Endovascular System
Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System
- Safety - Freedom from the occurrence of any new-onset major adverse event(s) [ 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.
- Efficacy - Primary Patency [ Time Frame: 12 months ]Primary patency defined as freedom from 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 PSVR >2.5:1).
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): NCT02802306
|Principal Investigator:||Marianne Brodmann, MD||Medical University Hospital Graz|