Arterial Occlusive Diseases, Peripheral Arterial Disease, Peripheral Vascular Diseases
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPTA (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.
Sponsors
C. R. Bard
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures. 2. Subject must be either a male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures. 3. Subject must be willing to comply with the protocol requirements, including the follow-up procedures. 4. Subject must have a target lesion (de novo lesion or prior failed treatment) that can be treated with the UltraScore™ Focused Force PTA balloon according to the Instructions for Use (IFU). Only a target lesion in the SFA, popliteal, or infra-popliteal arteries (posterior tibial, anterior tibial, or peroneal arteries) may be treated for this study. 5. Subject must have an Above the Knee (ATK) or Below the Knee (BTK) target lesion with at least one vessel run-off. 6. The target lesion must be able to be crossed using a guidewire (use of chronic total occlusion (CTO) or atherectomy is allowed).
Exclusion criteria
1. Subjects that are to receive one or more stents as adjunctive therapy at the target lesion (bail out stenting is allowed). 2. The subject has a single target lesion that involves both ATK and BTK arteries. 3. The subject has a target lesion in a previously placed stent or stent graft (in-stent restenosis). 4. The subject has a lesion, which in the opinion of the Investigator, would preclude safe use of the UltraScore™ Focused Force PTA balloon. 5. The subject has a flow limiting dissection at the target lesion prior to use of the UltraScore™ Focused Force PTA balloon. 6. The subject has acute limb ischemia. 7. The subject has been assessed Rutherford category 6. 8. The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated. 9. The subject has another medical condition or is currently participating in an investigational drug or another device study that, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Achieve Optimal PTA Results | 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). |
| Number of Participants With Technical Success of Use of UltraScore™ Focused Force PTA Balloon | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Did Not Have a Major Amputation of the Target Limb | 30 days post-index procedure | Major amputation is defined as above the ankle amputation |
| Number of Participants That Had Improved Clinical Measures From Baseline (ABI) | 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. |
| Number of Participants With Bail-out Stenting Due to Dissection | 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. |
| Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects | 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. |
| Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | 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 |
| Number of Participants That Did Not Have a Target Lesion Revascularization (TLR). | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 350 |
| Total | 350 |
Baseline characteristics
| Characteristic | PTA-UltraScore Focused Force PTA Balloon |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 230 Participants |
| Age, Categorical Between 18 and 65 years | 120 Participants |
| Age, Continuous | 70.2 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 80 Participants |
| Race (NIH/OMB) More than one race | 14 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) White | 239 Participants |
| Region of Enrollment United States | 350 participants |
| Sex: Female, Male Female | 112 Participants |
| Sex: Female, Male Male | 238 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 32 / 350 |
| other Total, other adverse events | 0 / 350 |
| serious Total, serious adverse events | 45 / 350 |
Outcome results
Primary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Achieve Optimal PTA Results | 254 Participants |
Primary
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.
Population: Number of participants treated with Ultrascore.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants With Technical Success of Use of UltraScore™ Focused Force PTA Balloon | 350 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Did Not Have a Major Amputation of the Target Limb | 253 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Did Not Have a Major Amputation of the Target Limb | 337 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Did Not Have a Major Amputation of the Target Limb | 303 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Did Not Have a Target Lesion Revascularization (TLR). | 232 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Did Not Have a Target Lesion Revascularization (TLR). | 343 Participants |
Secondary
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: 6 months post-index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Did Not Have a Target Lesion Revascularization (TLR). | 287 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects | 64 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects | 137 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects | 89 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (ABI) | 0.952 score on a scale | Standard Deviation 0.245 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (ABI) | 0.927 score on a scale | Standard Deviation 0.2188 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (ABI) | 0.988 score on a scale | Standard Deviation 0.1875 |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 5 | 12 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 0 | 112 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 1 | 30 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 2 | 22 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 3 | 23 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 4 | 12 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 6 | 0 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 0 | 142 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 1 | 57 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 2 | 32 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 3 | 14 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 4 | 11 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 5 | 43 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 6 | 2 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 2 | 22 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 0 | 118 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 1 | 39 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 3 | 25 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 4 | 10 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 5 | 13 Participants |
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) | RC 6 | 1 Participants |
Secondary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PTA-UltraScore Focused Force PTA Balloon | Number of Participants With Bail-out Stenting Due to Dissection | 14 Participants |