Multifunctional Angioplasty for Peripheral Artery Disease

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

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 1. Contrast volume administered during the revascularization portion of a procedure. 2. Number of catheter exchanges during revascularization 3. Fluoroscopy time 4. Radiation dose during revascularization 5. Procedure time post-enrollment 6. Equipment costs 7. Reduced use of supplies 8. Technical success 9. Safety/Major Adverse Peripheral Events On-treatment sample Intention-to-treat

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.

Is the Multifunctional Angioplasty treatment generally safe for humans?

Balloon angioplasty, a similar procedure, is considered safe for treating certain types of artery disease, and newer devices like atherectomy and laser angioplasty are being developed to improve safety and long-term benefits. ^{1 2 3 4 5}

How does the Multicath treatment for Peripheral Artery Disease differ from other treatments?

The Multicath treatment for Peripheral Artery Disease is unique because it combines different approaches, such as angioplasty and surgical techniques, to address multiple levels of arterial blockages, potentially leading to better outcomes and faster healing compared to traditional single-method treatments. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Multicath for Peripheral Artery Disease?

Research shows that combining different techniques, like angioplasty (a procedure to open blocked blood vessels) and surgical methods, can effectively improve blood flow and save limbs in patients with severe artery blockages. This suggests that using a multifunctional approach, like Multicath, could be beneficial for treating Peripheral Artery Disease. ^{6 11 12 13 14}

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

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]

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]

Citations

1. Italy pubmed.ncbi.nlm.nih.gov

Hybrid procedures for chronic lower limb ischemia: what determines the outcome? [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Reconstruction of "unreconstructable" critical limb ischemia with hybrid techniques. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular risk prevention in peripheral artery disease. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Combined percutaneous endovascular iliac angioplasty and infrainguinal surgical revascularization for chronic lower extremity ischemia: preliminary result. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Subintimal angioplasty of isolated infragenicular vessels in lower limb ischemia: long-term results. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Failure of surgical and endovascular infrainguinal and iliac procedures in the management of peripheral arterial disease using data from electronic medical records. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

New directions in percutaneous intervention for peripheral vascular disease. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Transbrachial Artery as Single or Combined Approach for Complex Interventions in Patients with Peripheral Artery Disease. [2023]

9. Italy pubmed.ncbi.nlm.nih.gov

Excimer laser atherectomy in complex peripheral artery disease: a prospective European registry. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Association of Anticoagulation and Major Adverse Limb Events After Index Peripheral Endovascular Intervention. [2023]

11. France pubmed.ncbi.nlm.nih.gov

[Percutaneous transluminal angioplasty of the terminal abdominal aorta. Apropos of a case with a review of the literature]. [2009]

12. United States pubmed.ncbi.nlm.nih.gov

Combined percutaneous transluminal angioplasty, iliac stent deployment, and femorofemoral bypass for bilateral aortoiliac occlusive disease. [2016]

13. United States pubmed.ncbi.nlm.nih.gov

A clinical trial of laser thermal angioplasty in patients with advanced peripheral vascular disease. [2019]

14. Italy pubmed.ncbi.nlm.nih.gov

Hybrid surgical and endovascular therapy in multifocal peripheral TASC D lesions: up to three-year follow-up. [2016]