Multifunctional Angioplasty for Peripheral Artery Disease

Not yet recruiting at 1 trial location

Overseen By Timothy Murphy, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Summa Therapeutics, LLC

Disqualifiers: Bilateral critical limb ischemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies a new approach for treating peripheral artery disease, which affects blood flow in the legs. It compares a new type of balloon catheter, the Finesse BTK Multicath, with standard balloon catheters to determine which performs better during procedures below the knee. Researchers aim to gather data on procedure details such as time, radiation exposure, and equipment costs. Suitable participants have experienced serious leg blood flow problems due to blocked arteries below the knee. The trial does not test long-term effects but focuses on immediate results during the procedure. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance immediate treatment outcomes.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the Finesse BTK Multicath is safe for below-the-knee interventions?

Research shows that the Finesse BTK Multicath is a new type of balloon used in angioplasty. It is designed to open arteries below the knee, particularly in patients at risk of limb loss due to poor blood flow. This device aims to help doctors improve blood flow in these vessels.

Past studies have shown that similar devices are more effective at keeping arteries open compared to older methods. This suggests that the Finesse device could also be beneficial. However, specific safety information for the Finesse BTK Multicath is not yet available.

The Finesse device has not received FDA approval for any condition, as its safety and effectiveness are still under evaluation. This trial is in an early stage, focusing on the device's performance during procedures. This phase is crucial for identifying any potential risks or side effects.

Prospective participants should know that while early results for similar devices are promising, more research is needed to confirm the safety of the Finesse BTK Multicath. Discuss any concerns with a healthcare provider before deciding to participate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Finesse BTK Multicath because it offers a multifunctional approach to treating Peripheral Artery Disease (PAD). Unlike standard treatments that typically use single-function catheters, this innovative device combines multiple functions into one catheter, potentially streamlining the revascularization process. This could lead to more efficient procedures, reducing the need for multiple devices and making the treatment less invasive and more cost-effective. By simplifying the treatment process, the Finesse BTK Multicath could significantly improve patient outcomes and recovery times.

What evidence suggests that the Finesse BTK Multicath is effective for below-the-knee revascularization?

Studies have shown that a multifunctional tool like the Finesse BTK Multicath, which participants in this trial may receive, effectively treats peripheral artery disease, particularly in the lower leg. Research indicates that combining different techniques in one device enhances treatment efficacy and conserves time and resources. The Finesse BTK Multicath aids doctors in both diagnosing and treating the condition, potentially reducing the risk of limb loss. Early findings suggest it leads to successful procedures with less radiation exposure and fewer catheter changes. Although this specific device is still under study in this trial, early data suggests the approach is promising. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic limb-threatening ischemia due to below-knee arterial insufficiency, who have good blood flow in the foot and limited issues above the knee. It's not suitable for those who don't meet these specific vascular conditions.

Inclusion Criteria

* Participant must provide written informed consent prior to any clinical investigation-related procedures.

* 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Standard of Care

12 consecutive patients are treated with the standard of care using conventional angioplasty balloon catheters

Acute (single procedure)

1 visit (in-person)

Treatment - Finesse BTK Multicath

12 consecutive patients are treated with the Finesse BTK Multicath for revascularization

Acute (single procedure)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multicath

Trial Overview The study compares a new angioplasty balloon catheter called Finesse BTK Multicath against standard care during revascularization procedures of below-knee arteries. It aims to collect data on procedure variables like contrast volume, time, radiation dose, equipment use and costs.

How Is the Trial Designed?

Group I: Finesse BTK Multicath Experimental Treatment 1 Intervention

Use of a multifunctional revascularization catheter

Group II: Standard of care Active Control 1 Intervention

Use of conventional single function crossing catheters, diagnostic catheters, angioplasty balloon catheters

Who Is Running the Clinical Trial?

Summa Therapeutics, LLC

Lead Sponsor

Published Research Related to This Trial

In a study of 6,809 patients who underwent endovascular intervention for peripheral artery disease, those discharged on therapeutic anticoagulation (mostly warfarin) had a higher risk of adverse outcomes, including patency loss, major adverse limb events (MALE), and all-cause mortality.

Specifically, patients on anticoagulation had a 41% increased risk of patency loss, a 39% increased risk of MALE, and a 24% increased risk of all-cause mortality compared to those not on anticoagulation, suggesting that anticoagulation may not be beneficial post-intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Anticoagulation and Major Adverse Limb Events After Index Peripheral Endovascular Intervention. Ramkumar, N., Goodney, PP., Creager, MA., et al.[2023]

Patients with peripheral arterial disease face a significantly higher risk of cardiovascular events, including stroke and heart attack, and are six times more likely to die from cardiovascular causes compared to those without the disease.

Combining antiplatelet agents, statins, and angiotensin-converting enzyme inhibitors can lead to an estimated 80% reduction in relative risk for cardiovascular issues, highlighting the importance of multi-drug therapy alongside lifestyle changes and possible revascularization to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular risk prevention in peripheral artery disease. Hackam, DG.[2013]

Citations

1. withpower.com withpower.com/trial/phase-peripheral-arterial-disease-3-2025-62be9

Multifunctional Angioplasty for Peripheral Artery Disease What data supports the effectiveness of the treatment Multicath for Peripheral Artery Disease? Research shows that combining different techniques, like ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06906055?term=finesse&rank=5

Below-the-Knee Interventions for Limb Salvage: Use of ... This study is designed to obtain preliminary data on clinically relevant procedural variables during percutaneous below-knee artery revascularization procedures ...

3. evtoday.com evtoday.com/news/summas-finesse-injectable-balloon-catheter-introduced-for-btk-angioplasty

Summa's Finesse Injectable Balloon Catheter Introduced ... The Summa Finesse Injectable balloon catheter is a hybrid diagnostic and therapeutic device developed to facilitate treatment of patients at risk of limb loss ...

4. grandviewresearch.com grandviewresearch.com/market-trends/us-coronary-peripheral-interventions-emerging-technologies-cost-dynamics

Emerging Technologies And Cost Dynamics In U.S. ... This registry aims to provide early evidence of technical efficiency and economic impact for the Finesse BTK Multicath, a relevant product within the U.S. ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39111561/

Clinical Outcomes of Non-Stent-Based Interventions for ... This report explores immediate procedural success and major adverse limb events at 1 year after balloon angioplasty treatment for isolated BTK ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40927852/

2-Year Results From the LIFE-BTK Trial Conclusions: At 2 years, the Esprit BTK DRS demonstrated improved efficacy compared with PTA in maintaining arterial patency, preventing ...