Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters

NCT06906055 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CT-0119-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

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; atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Contrast volume

  during the intervention/procedure/surgery

Other Outcomes (8)

• Procedure duration

  during the intervention

• Radiation dose

  during the intervention

• Fluoroscopy time

  during the intervention

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

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

Device: Standard of Care (SOC)

Finesse BTK Multicath

EXPERIMENTAL

Use of a multifunctional revascularization catheter

Device: Multicath

Interventions

Multicath DEVICE

Use of a multifunctional catheter for revascularization of blocked arteries below the knee

Finesse BTK Multicath

Standard of Care (SOC) DEVICE

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

Standard of care

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Summa Therapeutics, LLC: lead

Study Sites (2)

Endovascular Consultants

Wilmington, Delaware, 19805, United States

Location

Atlantic Medical Imaging

Vineland, New Jersey, 08360, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Diabetes Mellitus; Renal Insufficiency, Chronic; Gangrene; Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Timothy Murphy, M.D.

CONTACT

8772672685; info@summatherapeutics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: April 2, 2025
• Study Start: April 3, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)