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

Peripheral Arterial Disease Clinical Trial

Official title:

A Prospective, Multi-Center, Single-Arm, Real-World Study Assessing the Clinical Use of the Bard® UltraScore™ Focused Force PTA Balloon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193619
• Other study ID #: BPV-16-001
• Status: Completed
• Start date: March 28, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: October 2023
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: April 1, 2022
• Est. primary completion date: October 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	MedStar Health Research Institute	Annapolis	Maryland
United States	Cardiothoracic and Vascular Surgeons	Austin	Texas
United States	Willis Knighton Medical Center	Bossier City	Louisiana
United States	Beth Israel Deaconess Medical Center, Inc	Boston	Massachusetts
United States	SSM DePaul Health Center	Bridgeton	Missouri
United States	Montefiore Medical Center	Bronx	New York
United States	Health One Denver Heart	Denver	Colorado
United States	St. Joseph Hospital	Fort Wayne	Indiana
United States	Stern Cardiovascular Foundation, Inc	Germantown	Tennessee
United States	HSHS St. Vincent Hospital	Green Bay	Wisconsin
United States	East Carolina University	Greenville	North Carolina
United States	Baylor St. Luke's Health College of Medicine	Houston	Texas
United States	The Methodist Hospital Research Institute dba Houston Methodist Research Institute	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	US Cardiovascular Jefferson Hills	Jefferson Hills	Pennsylvania
United States	CIS Clinical Research Corporation	Lafayette	Louisiana
United States	University of Kentucky	Lexington	Kentucky
United States	Texas Tech University Health Science Center/University Medical Center	Lubbock	Texas
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	Community Hospital Munster Research Foundation	Munster	Indiana
United States	Mount Sinai School of Medicine	New York	New York
United States	Methodist Health System	Omaha	Nebraska
United States	Vascular Access Solutions	Orangeburg	South Carolina
United States	St. Luke's Hospital- Phoenix	Phoenix	Arizona
United States	Oregon Health & Science University	Portland	Oregon
United States	Rex Hospital, Inc	Raleigh	North Carolina
United States	St. Louis Univeristy	Saint Louis	Missouri
United States	Providence-Providence Park Hospital	Southfield	Michigan
United States	Staten Island University Hospital	Staten Island	New York
United States	Coastal Surgery Specialists	Wilmington	North Carolina
United States	Pinnacle Health Cardiovascular Institute	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Index procedure (Day 0); approximate duration of procedure is 90 minutes.
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.	Index procedure (Day 0); approximate duration of procedure is 90 minutes.
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.	Index procedure (Day 0); approximate duration of procedure is 90 minutes.
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	30 days post-index procedure
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	6 months post-index procedure
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	12 months post-index procedure
Secondary	Number of Participants That Did Not Have a Major Amputation of the Target Limb	Major amputation is defined as above the ankle amputation	30 days post-index procedure
Secondary	Number of Participants That Did Not Have a Major Amputation of the Target Limb	Major amputation is defined as above the ankle amputation	6 months post-index procedure
Secondary	Number of Participants That Did Not Have a Major Amputation of the Target Limb	Major amputation is defined as above the ankle amputation	12 months post-index procedure
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.	30 days post-index procedure
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.	6 months post-index procedure
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.	12 months post-index procedure
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; Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after >2 blocks (>600 feet, or 2 football fields); Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields); Severe claudication: ischemic limb muscle pain that limits walking to <1 block (<300 feet, or 1 football field); Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion; Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia; Major tissue loss: ischemic gangrene extending above TM level, functional foot no longer salvageable without extensive resvascularization efforts	30 days post-index procedure
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; Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after >2 blocks (>600 feet, or 2 football fields); Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields); Severe claudication: ischemic limb muscle pain that limits walking to <1 block (<300 feet, or 1 football field); Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion; Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia; Major tissue loss: ischemic gangrene extending above TM level, functional foot no longer salvageable without extensive resvascularization efforts	6 months post-index procedure
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; Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after >2 blocks (>600 feet, or 2 football fields); Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields); Severe claudication: ischemic limb muscle pain that limits walking to <1 block (<300 feet, or 1 football field); Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion; Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia; Major tissue loss: ischemic gangrene extending above TM level, functional foot no longer salvageable without extensive resvascularization efforts	12 months post-index procedure
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.	30 days post-index procedure
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.	6 months post-index procedure
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.	12 months post-index procedure