Trial Outcomes & Findings for Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon (NCT NCT03193619)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

350 participants

Primary outcome timeframe

Index procedure (Day 0); approximate duration of procedure is 90 minutes.

Results posted on

2024-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	350
Overall Study COMPLETED	349
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PTA-UltraScore Focused Force PTA Balloon n=350 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	120 Participants n=5 Participants
Age, Categorical >=65 years	230 Participants n=5 Participants
Age, Continuous	70.2 years n=5 Participants
Sex: Female, Male Female	112 Participants n=5 Participants
Sex: Female, Male Male	238 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	80 Participants n=5 Participants
Race (NIH/OMB) White	239 Participants n=5 Participants
Race (NIH/OMB) More than one race	14 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants
Region of Enrollment United States	350 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=349 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants That Achieve Optimal PTA Results	254 Participants

PRIMARY outcome

Timeframe: Index procedure (Day 0); approximate duration of procedure is 90 minutes.

Population: Number of participants treated with Ultrascore.

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.

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=350 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants With Technical Success of Use of UltraScore™ Focused Force PTA Balloon	350 Participants

SECONDARY outcome

Timeframe: Index procedure (Day 0); approximate duration of procedure is 90 minutes.

Number of participants who needed stent placement for abrupt or threatened artery closure caused by arterial dissection immediately following index procedure.

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=350 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants With Bail-out Stenting Due to Dissection	14 Participants

SECONDARY outcome

Timeframe: 30 days post-index procedure

TLR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in target vessel after the index procedure

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=343 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).	343 Participants

SECONDARY outcome

Timeframe: 6 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

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=307 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).	287 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=263 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).	232 Participants

SECONDARY outcome

Timeframe: 30 days post-index procedure

Major amputation is defined as above the ankle amputation

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=346 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants That Did Not Have a Major Amputation of the Target Limb	337 Participants

SECONDARY outcome

Timeframe: 6 months post-index procedure

Major amputation is defined as above the ankle amputation

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=320 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants That Did Not Have a Major Amputation of the Target Limb	303 Participants

SECONDARY outcome

Timeframe: 12 months post-index procedure

Major amputation is defined as above the ankle amputation

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=271 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants That Did Not Have a Major Amputation of the Target Limb	253 Participants

SECONDARY outcome

Timeframe: 30 days post-index procedure

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.

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=249 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants That Had Improved Clinical Measures From Baseline (ABI)	0.988 score on a scale Standard Deviation 0.1875

SECONDARY outcome

Timeframe: 6 months post-index procedure

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.

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=191 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants That Had Improved Clinical Measures From Baseline (ABI)	0.927 score on a scale Standard Deviation 0.2188

SECONDARY outcome

Timeframe: 12 months post-index procedure

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.

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=178 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants That Had Improved Clinical Measures From Baseline (ABI)	0.952 score on a scale Standard Deviation 0.2450

SECONDARY outcome

Timeframe: 30 days post-index procedure

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

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=301 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 0	142 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 1	57 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 2	32 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 3	14 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 4	11 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 5	43 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 6	2 Participants

SECONDARY outcome

Timeframe: 6 months post-index procedure

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

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=228 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 0	118 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 1	39 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 2	22 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 3	25 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 4	10 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 5	13 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 6	1 Participants

SECONDARY outcome

Timeframe: 12 months post-index procedure

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

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=211 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 0	112 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 1	30 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 2	22 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 3	23 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 4	12 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 5	12 Participants
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) RC 6	0 Participants

SECONDARY outcome

Timeframe: 30 days post-index procedure

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.

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=144 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects	137 Participants

SECONDARY outcome

Timeframe: 6 months post-index procedure

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.

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=111 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects	89 Participants

SECONDARY outcome

Timeframe: 12 months post-index procedure

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.

Outcome measures

Outcome measures
Measure	PTA-UltraScore Focused Force PTA Balloon n=104 Participants Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects	64 Participants

Adverse Events

PTA-UltraScore Focused Force PTA Balloon

Serious events: 45 serious events

Other events: 0 other events

Deaths: 32 deaths

Serious adverse events

Serious adverse events
Measure	PTA-UltraScore Focused Force PTA Balloon n=350 participants at risk Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. 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.
Vascular disorders Vascular disorders	12.6% 44/350 • Number of events 44 • 3 years and 7 months
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	0.29% 1/350 • Number of events 1 • 3 years and 7 months
Vascular disorders Peripheral arterial reocclusion	0.29% 1/350 • Number of events 1 • 3 years and 7 months

Other adverse events

Adverse event data not reported

Additional Information

Anna Lovas

Becton, Dickinson, and Company

Phone: 952-239-0548

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place