The objective of this study is to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon in a heterogeneous patient population in a real world, on-label clinical application.
The registry is a prospective, multi-center, single-arm, real-world study to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon for the treatment of stenotic lesions of the superficial femoral artery (SFA), popliteal artery, and infra-popliteal arteries (posterior tibial, anterior tibial and peroneal arteries). Follow-up for all treated subjects will be performed at hospital discharge, 30 days, and 6 and 12 months post-index procedure.
Study Type
OBSERVATIONAL
Enrollment
350
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.
Number of Participants That Achieve Optimal PTA Results
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).
Time frame: Index procedure (Day 0); approximate duration of procedure is 90 minutes.
Number of Participants With Technical Success of Use of UltraScore™ Focused Force PTA Balloon
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.
Time frame: Index procedure (Day 0); approximate duration of procedure is 90 minutes.
Number of Participants With Bail-out Stenting Due to Dissection
Number of participants who needed stent placement for abrupt or threatened artery closure caused by arterial dissection immediately following index procedure.
Time frame: Index procedure (Day 0); approximate duration of procedure is 90 minutes.
Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).
TLR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in target vessel after the index procedure
Time frame: 30 days post-index procedure
Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).
TLR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in target vessel after the index procedure
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St. Luke's Hospital- Phoenix
Phoenix, Arizona, United States
Health One Denver Heart
Denver, Colorado, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
St. Joseph Hospital
Fort Wayne, Indiana, United States
Community Hospital Munster Research Foundation
Munster, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Willis Knighton Medical Center
Bossier City, Louisiana, United States
CIS Clinical Research Corporation
Lafayette, Louisiana, United States
MedStar Health Research Institute
Annapolis, Maryland, United States
...and 21 more locations
Time frame: 6 months post-index procedure
Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).
TLR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in target vessel after the index procedure
Time frame: 12 months post-index procedure
Number of Participants That Did Not Have a Major Amputation of the Target Limb
Major amputation is defined as above the ankle amputation
Time frame: 30 days post-index procedure
Number of Participants That Did Not Have a Major Amputation of the Target Limb
Major amputation is defined as above the ankle amputation
Time frame: 6 months post-index procedure
Number of Participants That Did Not Have a Major Amputation of the Target Limb
Major amputation is defined as above the ankle amputation
Time frame: 12 months post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (ABI)
Resting ankle brachial index (ABI) for chronic limb ischemia measurements will be assessed clinically at follow-up and compared with baseline. ABI measurements: Mild to moderate if the ABI is between 0.4 and 0.9, and an ABI less than 0.40 is suggestive of severe PAD \[19\]. An ABI value greater than 1.3 is also considered abnormal, suggestive of non-compressible vessels.
Time frame: 30 days post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (ABI)
Resting ankle brachial index (ABI) for chronic limb ischemia measurements will be assessed clinically at follow-up and compared with baseline. ABI measurements: Mild to moderate if the ABI is between 0.4 and 0.9, and an ABI less than 0.40 is suggestive of severe PAD \[19\]. An ABI value greater than 1.3 is also considered abnormal, suggestive of non-compressible vessels.
Time frame: 6 months post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (ABI)
Resting ankle brachial index (ABI) for chronic limb ischemia measurements will be assessed clinically at follow-up and compared with baseline. ABI measurements: Mild to moderate if the ABI is between 0.4 and 0.9, and an ABI less than 0.40 is suggestive of severe PAD \[19\]. An ABI value greater than 1.3 is also considered abnormal, suggestive of non-compressible vessels.
Time frame: 12 months post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification)
Rutherford classification (RC): 0 Asymptomatic: documented peripheral arterial disease, without symptoms of claudication or ischemic pain 1. Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after \>2 blocks (\>600 feet, or 2 football fields) 2. Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields) 3. Severe claudication: ischemic limb muscle pain that limits walking to \<1 block (\<300 feet, or 1 football field) 4. Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion 5. Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia 6. Major tissue loss: ischemic gangrene extending above TM level, functional foot no longer salvageable without extensive resvascularization efforts
Time frame: 30 days post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification)
Rutherford classification (RC): 0 Asymptomatic: documented peripheral arterial disease, without symptoms of claudication or ischemic pain 1. Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after \>2 blocks (\>600 feet, or 2 football fields) 2. Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields) 3. Severe claudication: ischemic limb muscle pain that limits walking to \<1 block (\<300 feet, or 1 football field) 4. Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion 5. Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia 6. Major tissue loss: ischemic gangrene extending above TM level, functional foot no longer salvageable without extensive resvascularization efforts
Time frame: 6 months post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification)
Rutherford classification (RC): 0 Asymptomatic: documented peripheral arterial disease, without symptoms of claudication or ischemic pain 1. Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after \>2 blocks (\>600 feet, or 2 football fields) 2. Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields) 3. Severe claudication: ischemic limb muscle pain that limits walking to \<1 block (\<300 feet, or 1 football field) 4. Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion 5. Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia 6. Major tissue loss: ischemic gangrene extending above TM level, functional foot no longer salvageable without extensive resvascularization efforts
Time frame: 12 months post-index procedure
Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects
ATK subjects have a target lesion of the SFA or popliteal artery only. Primary patency (patent or open target vessel) is measured by duplex ultrasound (DUS) core lab; the core lab determines whether target vessel is patent/open.
Time frame: 30 days post-index procedure
Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects
ATK subjects have a target lesion of the SFA or popliteal artery only. Primary patency (patent or open target vessel) is measured by duplex ultrasound (DUS) core lab; the core lab determines whether target vessel is patent/open.
Time frame: 6 months post-index procedure
Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects
ATK subjects have a target lesion of the SFA or popliteal artery only. Primary patency (patent or open target vessel) is measured by duplex ultrasound (DUS) core lab; the core lab determines whether target vessel is patent/open.
Time frame: 12 months post-index procedure