Peripheral Arterial DiseaseNCT03193619
Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon
An observational study of Peripheral Arterial Disease and Peripheral Vascular Diseases, run by C. R. Bard at 31 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Arterial Occlusive Diseases
- What is being tested?
- PTA (UltraScore Focused Force PTA Balloon)
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 31 sitesUnited States
- Study dates
- 28 Mar 2018to 1 Apr 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include a maximum of 350 subjects at up to 45 U.S. sites. All subjects will have peripheral arterial disease (PAD; a stenotic lesion of the SFA, popliteal, or infra-popliteal arteries).
Who may be able to join
- Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
- 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.
- Subject must be willing to comply with the protocol requirements, including the follow-up procedures.
- 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.
- Subject must have an Above the Knee (ATK) or Below the Knee (BTK) target lesion with at least one vessel run-off.
- The target lesion must be able to be crossed using a guidewire (use of chronic total occlusion (CTO) or atherectomy is allowed).
Who cannot join
- Subjects that are to receive one or more stents as adjunctive therapy at the target lesion (bail out stenting is allowed).
- The subject has a single target lesion that involves both ATK and BTK arteries.
- The subject has a target lesion in a previously placed stent or stent graft (in-stent restenosis).
- The subject has a lesion, which in the opinion of the Investigator, would preclude safe use of the UltraScore™ Focused Force PTA balloon.
- The subject has a flow limiting dissection at the target lesion prior to use of the UltraScore™ Focused Force PTA balloon.
- The subject has acute limb ischemia.
Show all 9Show fewer
- The subject has been assessed Rutherford category 6.
- The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
- 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.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
MedStar Health Research Institute
Annapolis, Maryland, 21401
Cardiothoracic and Vascular Surgeons
Austin, Texas, 78746
Willis Knighton Medical Center
Bossier City, Louisiana, 71112
Beth Israel Deaconess Medical Center, Inc
Boston, Massachusetts, 02215
SSM DePaul Health Center
Bridgeton, Missouri, 63044
Health One Denver Heart
Denver, Colorado, 80220
St. Joseph Hospital
Fort Wayne, Indiana, 46802
Stern Cardiovascular Foundation, Inc
Germantown, Tennessee, 38138
HSHS St. Vincent Hospital
Green Bay, Wisconsin, 54301
East Carolina University
Greenville, North Carolina, 27858
Baylor St. Luke's Health College of Medicine
Houston, Texas, 77030
The Methodist Hospital Research Institute dba Houston Methodist Research Institute
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
US Cardiovascular Jefferson Hills
Jefferson Hills, Pennsylvania, 15025
CIS Clinical Research Corporation
Lafayette, Louisiana, 70506
University of Kentucky
Lexington, Kentucky, 40536
Texas Tech University Health Science Center/University Medical Center
Lubbock, Texas, 79430
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Community Hospital Munster Research Foundation
Munster, Indiana, 46321
Mount Sinai School of Medicine
New York, New York, 10029
Methodist Health System
Omaha, Nebraska, 68114
Vascular Access Solutions
Orangeburg, South Carolina, 29118
St. Luke's Hospital- Phoenix
Phoenix, Arizona, 85006
Oregon Health & Science University
Portland, Oregon, 97239
Rex Hospital, Inc
Raleigh, North Carolina, 27607
Providence-Providence Park Hospital
Southfield, Michigan, 48075
St. Louis Univeristy
St Louis, Missouri, 63103
Staten Island University Hospital
Staten Island, New York, 10305
Montefiore Medical Center
The Bronx, New York, 10467
Coastal Surgery Specialists
Wilmington, North Carolina, 28401
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, 17043
About this study
Official title: A Prospective, Multi-Center, Single-Arm, Real-World Study Assessing the Clinical Use of the Bard® UltraScore™ Focused Force PTA Balloon
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.
Read the 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.
- Being tested
- PTA (UltraScore Focused Force PTA Balloon)
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTA (UltraScore Focused Force PTA Balloon)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PTA (UltraScore Focused Force PTA Balloon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Index procedure (Day 0); approximate duration of procedure is 90 minutes.
Secondary outcomes (16)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
- 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
Measured: 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
- 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
Measured: 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
- 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start28 Mar 2018
- Primary completion29 Oct 2020
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Craig Walker, MD, Principal investigator, Cardiovascular Institute of the South (CIS) Clinical Research CorporationRobert Beasley, MD, Principal investigator, Icahn School of Medicine at Mount SinaiMiguel Montero, MD, Principal investigator, Baylor St. Luke's College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193619
- Sponsor's protocol ID
- BPV-16-001
- Status last verified
- Oct 2023
- First submitted
- 19 Jun 2017
- Last updated
- 28 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Single-Arm, Real-World Study Assessing the Clinical Use of the Bard® UltraScore™ Focused Force PTA Balloon
- ClinicalTrials.gov ID
- NCT03193619
- Acronym / sponsor ID
- BPV-16-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 29 Oct 2020 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Posted 28 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTA-UltraScore Focused Force PTA balloon | – | Device: 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include a maximum of 350 subjects at up to 45 U.S. sites. All subjects will have peripheral arterial disease (PAD; a stenotic lesion of the SFA, popliteal, or infra-popliteal arteries).
Key inclusion criteria (6 listed)
- Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
- 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.
- Subject must be willing to comply with the protocol requirements, including the follow-up procedures.
- 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.
- Subject must have an Above the Knee (ATK) or Below the Knee (BTK) target lesion with at least one vessel run-off.
Key exclusion criteria (9 listed)
- Subjects that are to receive one or more stents as adjunctive therapy at the target lesion (bail out stenting is allowed).
- The subject has a single target lesion that involves both ATK and BTK arteries.
- The subject has a target lesion in a previously placed stent or stent graft (in-stent restenosis).
- The subject has a lesion, which in the opinion of the Investigator, would preclude safe use of the UltraScore™ Focused Force PTA balloon.
- The subject has a flow limiting dissection at the target lesion prior to use of the UltraScore™ Focused Force PTA balloon.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | PTA-UltraScore Focused Force PTA balloon |
Primary outcome
Number of Participants That 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).
Number of Participants With 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.
16 secondary outcomes
Number of Participants With Bail-out Stenting Due to Dissection
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).
Time frame: 30 days post-index procedure
Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).
Time frame: 6 months post-index procedure
Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).
Time frame: 12 months post-index procedure
Number of Participants That Did Not Have a Major Amputation of the Target Limb
Time frame: 30 days post-index procedure
Number of Participants That Did Not Have a Major Amputation of the Target Limb
Time frame: 6 months post-index procedure
Number of Participants That Did Not Have a Major Amputation of the Target Limb
Time frame: 12 months post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (ABI)
Time frame: 30 days post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (ABI)
Time frame: 6 months post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (ABI)
Time frame: 12 months post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification)
Time frame: 30 days post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification)
Time frame: 6 months post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification)
Time frame: 12 months post-index procedure
Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects
Time frame: 30 days post-index procedure
Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects
Time frame: 6 months post-index procedure
Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects
Time frame: 12 months post-index procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Walker, MD principal investigator
Cardiovascular Institute of the South (CIS) Clinical Research Corporation
Robert Beasley, MD principal investigator
Icahn School of Medicine at Mount Sinai
Miguel Montero, MD principal investigator
Baylor St. Luke's College of Medicine
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Peripheral Vascular Diseases, run by C. R. Bard at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Achieve Optimal PTA Results (time frame: Index procedure (Day 0); approximate duration of procedure is 90 minutes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.