Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03193619|
Recruitment Status : Active, not recruiting
First Posted : June 21, 2017
Last Update Posted : September 21, 2021
|Condition or disease||Intervention/treatment|
|Peripheral Arterial Disease Peripheral Vascular Diseases Arterial Occlusive Diseases||Device: PTA (UltraScore Focused Force PTA Balloon)|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||350 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||A Prospective, Multi-Center, Single-Arm, Real-World Study Assessing the Clinical Use of the Bard® UltraScore™ Focused Force PTA Balloon|
|Actual Study Start Date :||March 28, 2018|
|Actual Primary Completion Date :||October 29, 2020|
|Estimated Study Completion Date :||November 29, 2021|
PTA-UltraScore Focused Force PTA balloon
Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU.
Device: PTA (UltraScore Focused Force PTA Balloon)
Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
The UltraScore Focused Force PTA balloon through the blood vessel to the narrowed area to be treated.
- Achieve optimal PTA results [ Time Frame: Index procedure (Day 0); approximate duration of procedure is 90 minutes. ]Optimal result is defined as ≤30% residual stenosis without major flow-limiting dissection, as measured by angiographic imaging. Major flow limiting dissections are classified by the National Heart, Lung, and Blood Institute (NHLBI) as Grade D (Spiral luminal filling defects), Grade E (Appearance of new and persistent filling defects with reduced flow), and Grade F (Total occlusion without distal flow).
- Technical success of use of UltraScore™ Focused Force PTA balloon [ Time Frame: Index procedure (Day 0); approximate duration of procedure is 90 minutes. ]Technical success is determined subjectively by the investigator according to delivery location of the study device relative to the target lesion, as assessed by angiographic imaging, and inflation without movement.
- Rate of bail-out stenting due to dissection [ Time Frame: Index procedure (Day 0); approximate duration of procedure is 90 minutes. ]Rate of emergency artery stent placement for abrupt or threatened artery closure caused by arterial dissection immediately following index procedure.
- Freedom from target lesion revascularization (TLR). [ Time Frame: 30 days, 6 months, and 12 months post-index procedure ]TLR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in target vessel after the index procedure
- Freedom from major amputation of the target limb [ Time Frame: 30 days, 6 months, and 12 months post-index procedure ]Major amputation is defined as above the ankle amputation
- Improved clinical measures from baseline [ Time Frame: 30 days, 6 months, and 12 months post-index procedure ]Resting ankle brachial index (ABI) and Rutherford classification for chronic limb ischemia measurements will be assessed clinically at follow-up and compared with baseline.
- Primary patency for Above the Knee (ATK) subjects [ Time Frame: 30 days, 6 months, and 12 months post-index procedure ]ATK subjects have a target lesion of the SFA or popliteal artery only. Primary patency is measured by duplex ultrasound (DUS) core lab; a peak systolic velocity ratio (PSVR) ≥2.5 suggests 50% restenosis and loss of patency.
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): NCT03193619
|Principal Investigator:||Craig Walker, MD||Cardiovascular Institute of the South (CIS) Clinical Research Corporation|
|Principal Investigator:||Robert Beasley, MD||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||Miguel Montero, MD||Baylor St. Luke's College of Medicine|