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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Arterial Disease Below the Knee; Peripheral Arterial Disease, Rutherford 4 and 5 with Possibility to Improve Vascularization
• Intervention / Treatment: Device: Standard of Care (SOC); Device: Multicath

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Timothy Murphy, M.D.; Phone Number: 8772672685; Email: info@summatherapeutics.com

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19805
      • EndoVascular Consultants
      • Contact: Laurie Francoeur; Phone Number: 8772672685; Email: lfrancoeur@orcaresearchgroup.com
  • New Jersey
    • Vineland, New Jersey, United States, 08360
      • Atlantic Medical Imaging
      • Contact: Laurie Francoeur; Phone Number: 8772672685; Email: lfrancoeur@orcaresearchgroup.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care; Use of conventional single function crossing catheters, diagnostic catheters, angioplasty balloon catheters	Device: Standard of Care (SOC); Use of single function crossing catheters, diagnostic catheters, angioplasty balloon catheters
Experimental: Finesse BTK Multicath; Use of a multifunctional revascularization catheter	Device: Multicath; Use of a multifunctional catheter for revascularization of blocked arteries below the knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Contrast volume	during the intervention/procedure/surgery

Other Outcome Measures

Outcome Measure	Time Frame
Procedure duration	during the intervention
Radiation dose	during the intervention
Fluoroscopy time	during the intervention
Number of catheter exchanges	during the intervention
Equipment costs	during the intervention
Rate of use of microcatheters or diagnostic catheters	during the intervention/procedure/surgery
Rate of technically successful revascularization of a continuous artery in the calf	during the intervention/procedure/surgery
Adverse events	during the intervention

Collaborators and Investigators

• Sponsor: Summa Therapeutics, LLC

Study record dates

Study Major Dates

• Study Start (Estimated): April 3, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: diabetes; chronic kidney disease; atherosclerosis; rest pain; angioplasty; amputation; gangrene; ischemic ulcer; limb threatening ischemia
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Metaplasia; Peripheral Arterial Disease; Peripheral Vascular Diseases; Neovascularization, Pathologic
• Other Study ID Numbers: CT-0119-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No