Peripheral Arterial Disease Below the KneeNCT06906055
Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters
A study testing Multicath in people with Peripheral Arterial Disease Below the Knee and Peripheral Arterial Disease, Rutherford 4 and 5 with Possibility to Improve Vascularization, run by Summa Therapeutics, LLC at 2 sites in United States.
Trial summary
Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters ("BTK Multicath Registry") A non-randomized clinical registry This study is designed to obtain preliminary data on clinically relevant procedural variables during percutaneous below-knee artery revascularization… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Peripheral Arterial Disease Below the Knee, Peripheral Arterial Disease, Rutherford 4 and 5 with Possibility to Improve Vascularization
- What is being tested?
- Multicath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Apr 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must provide written informed consent prior to any clinical investigation-related procedures.
- Age ≥ 18 years
- Planned lower extremity catheter-based revascularization for Rutherford 4 through 6 chronic limb-threatening ischemia (Table 1)
- Stenotic (>=70% stenosis by visual estimate) or occlusive lesion in an infrapopliteal artery (anterior tibial, peroneal, or posterior tibial) by angiography
- Target lesion up to 25cm in length by angiography
Who cannot join
- Participation in another clinical investigation that has not yet completed its primary end point.
- Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population.
- Female subjects of childbearing potential unless negative pregnancy test or contraceptive use
- Bilateral critical limb ischemia
- Planned bilateral vascular intervention
- Lack of reconstitution of foot runoff vessels at ankle joint
- Planned below-the-ankle intervention after completion of diagnostic angiography
- Planned suprainguinal intervention ->=5cm with at least 50% stenosis of the above knee femoro-popliteal artery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Atlantic Medical Imaging
Vineland, New Jersey, 08360
Laurie Francoeur, 8772672685, lfrancoeur@orcaresearchgroup.com
Endovascular Consultants
Wilmington, Delaware, 19805
Laurie Francoeur, 8772672685, lfrancoeur@orcaresearchgroup.com
About this study
Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters ("BTK Multicath Registry")
A non-randomized clinical registry
Read more
This study is designed to obtain preliminary data on clinically relevant procedural variables during percutaneous below-knee artery revascularization procedures among consecutive patients treated with either the Finesse BTK Multicath® ("Finesse") or the standard of care using conventional angioplasty balloon catheters.
This registry will enroll participants with a history of chronic limb threatening ischemia and below-knee arterial insufficiency who will be assigned to revascularization with or without use of the Finesse BTK Multicath. The registry is an acute study examining procedural data only. The primary endpoints of interest are the volume of contrast used for the intervention, overall procedure time, radiation dose, number of catheter exchanges during revascularization, and medical device supply costs. For the first phase 12 consecutive patients will be treated with the standard of care. For the second phase 12 consecutive patients will be treated with Finesse.
24 participants total
Up to 5 study sites in the United States
Initial anticipated enrollment: Q4 2024 Last anticipated enrollment: Q2 2025
Patients >=18 years old with documented history of unilateral chronic limb threatening ischemia due to below-knee arterial insufficiency with angiographic runoff in the foot and limited arterial insufficiency above the knee
- Contrast volume administered during the revascularization portion of a procedure.
- Number of catheter exchanges during revascularization
- Fluoroscopy time
- Radiation dose during revascularization
- Procedure time post-enrollment
- Equipment costs
- Reduced use of supplies
- Technical success
- Safety/Major Adverse Peripheral Events
On-treatment sample Intention-to-treat
- Conditions
- Peripheral Arterial Disease Below the Knee, Peripheral Arterial Disease, Rutherford 4 and 5 with Possibility to Improve Vascularization
- Being tested
- Multicath, Standard of Care (SOC)
- Keywords
- angioplasty, limb threatening ischemia, amputation, diabetes, chronic kidney disease, ischemic ulcer, rest pain, gangrene, atherosclerosis
- Medical subject headings
- Peripheral Arterial Disease, Diabetes Mellitus, Renal Insufficiency, Chronic, Gangrene, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MulticathDevice
Use of a multifunctional catheter for revascularization of blocked arteries below the knee
Standard of Care (SOC)Device
Use of single function crossing catheters, diagnostic catheters, angioplasty balloon catheters
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Use of conventional single function crossing catheters, diagnostic catheters, angioplasty balloon catheters Receives: Device: Standard of Care (SOC) |
| Finesse BTK Multicath | Experimental | Use of a multifunctional revascularization catheter Receives: Device: Multicath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast volume
Measured: during the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start3 Apr 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease Below the KneeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Summa Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906055
- Sponsor's protocol ID
- CT-0119-01
- Status last verified
- Mar 2025
- First submitted
- 19 Feb 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters
- ClinicalTrials.gov ID
- NCT06906055
- Acronym / sponsor ID
- CT-0119-01
- Conditions
- Peripheral Arterial Disease Below the Knee, Peripheral Arterial Disease, Rutherford 4 and 5 with Possibility to Improve Vascularization
- Keywords
- angioplasty, limb threatening ischemia, amputation, diabetes, chronic kidney disease, ischemic ulcer, rest pain, gangrene
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Summa Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters ("BTK Multicath Registry")
A non-randomized clinical registry
This study is designed to obtain preliminary data on clinically relevant procedural variables during percutaneous below-knee artery revascularization procedures among consecutive patients treated with either the Finesse BTK Multicath® ("Finesse") or the standard of care using conventional angioplasty balloon catheters.
This registry will enroll participants with a history of chronic limb threatening ischemia and below-knee arterial insufficiency who will be assigned to revascularization with or without use of the Finesse BTK Multicath. The registry is an acute study examining procedural data only. The primary endpoints of interest are the volume of contrast used for the intervention, overall procedure time, radiation dose, number of catheter exchanges during revascularization, and medical device supply costs. For the first phase 12 consecutive patients will be treated with the standard of care. For the second phase 12 consecutive patients will be treated with Finesse.
24 participants total
Up to 5 study sites in the United States
Initial anticipated enrollment: Q4 2024 Last anticipated enrollment: Q2 2025
Patients >=18 years old with documented history of unilateral chronic limb threatening ischemia due to below-knee arterial insufficiency with angiographic runoff in the foot and limited arterial insufficiency above the knee
- Contrast volume administered during the revascularization portion of a procedure.
- Number of catheter exchanges during revascularization
- Fluoroscopy time
- Radiation dose during revascularization
- Procedure time post-enrollment
- Equipment costs
- Reduced use of supplies
- Technical success
- Safety/Major Adverse Peripheral Events
On-treatment sample Intention-to-treat
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Device: Standard of Care (SOC)Use of conventional single function crossing catheters, diagnostic catheters, angioplasty balloon catheters |
| Finesse BTK Multicath | Experimental | Device: MulticathUse of a multifunctional revascularization catheter |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must provide written informed consent prior to any clinical investigation-related procedures.
- Age ≥ 18 years
- Planned lower extremity catheter-based revascularization for Rutherford 4 through 6 chronic limb-threatening ischemia (Table 1)
- Stenotic (>=70% stenosis by visual estimate) or occlusive lesion in an infrapopliteal artery (anterior tibial, peroneal, or posterior tibial) by angiography
- Target lesion up to 25cm in length by angiography
Key exclusion criteria (8 listed)
- Participation in another clinical investigation that has not yet completed its primary end point.
- Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population.
- Female subjects of childbearing potential unless negative pregnancy test or contraceptive use
- Bilateral critical limb ischemia
- Planned bilateral vascular intervention
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 |
|---|---|---|
| MulticathUse of a multifunctional catheter for revascularization of blocked arteries below the knee | Device | Finesse BTK Multicath |
| Standard of Care (SOC)Use of single function crossing catheters, diagnostic catheters, angioplasty balloon catheters | Device | Standard of care |
Primary outcome
Contrast volume
Time frame: during the intervention/procedure/surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Peripheral Arterial Disease Below the Knee
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A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)
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A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the Knee
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IVUS Guidance in BTK Interventions
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicath in people with Peripheral Arterial Disease Below the Knee and Peripheral Arterial Disease, Rutherford 4 and 5 with Possibility to Improve Vascularization, run by Summa Therapeutics, LLC at 2 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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy Murphy, M.D. (8772672685, info@summatherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast volume (time frame: during the intervention/procedure/surgery). 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 2 Apr 2025.