Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia

NCT06122974 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CP-006
• Study Type: interventional
• Target: 518
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this trial is to evaluate the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA. The Drug Eluting Temporary Spur Stent System is intended for use as a primary treatment in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (3)

• Phase A: Primary Safety Endpoint

  Freedom from the occurrence of major adverse limb events (MALE), and peri-operative death (POD), in Drug Eluting Temporary Spur Stent System and PTA-treated subjects through 30 days post-procedure. MALE are defined as: * Major amputation above the ankle * Major (open vascular surgery) reintervention * Target vessel thrombectomy or thrombolysis

  30 Days

• Phase B: Primary Safety Endpoint

  Freedom from the occurrence of POD at 30 days, and the occurrence of MALE at 6 months.

  30 Days & 6 Months

• Phase B: Primary Efficacy Endpoint

  Freedom from a composite endpoint of the occurrence of limb salvage and primary patency events at 6 months, defined as: * Clinically-driven target lesion revascularization (CD-TLR). * Above the ankle amputation in the index limb, in the presence of a totally occluded target vessel. * 100% total occlusion of target lesion in Spur and PTA-treated subjects.

  6 Months

Study Arms (2)

Study Device

OTHER

Subjects randomized to the Drug Eluting Temporary Spur Stent System

Device: Drug Eluting Temporary Spur Stent System

Control

OTHER

Subjects randomized to the PTA

Device: Percutaneous Transluminal Balloon Angioplasty

Interventions

Percutaneous Transluminal Balloon Angioplasty DEVICE

A balloon catheter is inserted across a lesion and inflated to fracture and compress the plaque, creating a larger lumen and improved blood flow through the artery.

Control

Drug Eluting Temporary Spur Stent System DEVICE

The Spur Stent consists of a sirolimus coated stent and balloon that is retrievable after delivery of the sirolimus formulation.

Study Device

Eligibility Criteria

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

You may qualify if:

• Subject willing and able to provide informed consent and able to comply with the study protocol and follow up. Subjects who are unable to sign due to a physical limitation may have a Legally Authorized Representative (LAR), including a family member, sign on their behalf.
• Life expectancy greater than 1 year in the investigator's opinion.
• Subject is greater than 18 years of age.
• Subjects must have chronic (greater than 14 days) symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 4-5, rest pain (R4), and/or minor tissue loss (R5), that in the opinion of the investigator are not amenable to conservative medical therapy and require endovascular intervention for alleviation of symptoms and tissue preservation.
• For subjects with bilateral disease, planned treatment of the contralateral limb must either be performed greater than or equal to 7 days prior to the index procedure or greater than or equal to 30 days following the index procedure.
• Stenotic, restenotic, or occlusive lesions with greater than or equal to 70% stenosis located in the infrapopliteal vessels, with target lesion that can be successfully crossed with a guidewire via the true lumen.
• Iliac, Superficial Femoral Artery (SFA) and popliteal inflow lesions can be treated using standard of care during the index procedure
• Note:
• Inflow lesions treated intraprocedure must be treated first, prior to consideration of treatment of infrapopliteal lesions.
• Treatment of in-stent restenosis in inflow treatment is permitted, provided that stents are not severely fractured or otherwise compromised.
• Distal embolic protection is strongly encouraged in cases where atherectomy is used.
• Inflow lesions must have a healthy vessel segment of greater than 30 mm between the study lesion and the treated segment, defined as less than 50% stenosis without aneurysmal segments.
• Inflow treatment must be successful, prior to treatment of the target lesion, resulting in stenosis less than or equal to 30%, without resulting flow limiting (Type D or greater) dissection, thrombus, or aneurysm by angiography prior to randomization.
• Target vessel reconstitutes at or above the ankle, with the target treated segment ending at least 10 mm above the ankle joint.
• Note:

You may not qualify if:

• Subject unwilling or unlikely to comply with the 5-year duration of the study in the opinion of the investigator.
• Subject is pregnant or planning to become pregnant during the course of the trial.
• Subject is breastfeeding or planning to breastfeed during the course of the trial.
• Subject has an active systemic infection that is not controlled at the time of the procedure, including septicemia or bacteremia.
• Subject has osteomyelitis proximal to the phalanges of the target foot. Osteomyelitis in the digit(s) of the target foot is permitted.
• Wounds in the target limb must be confined to the foot below the ankle.
• Heel wounds on the target foot are excluded; wounds on the plantar surface of the hindfoot are permitted.
• Planned major (above the ankle) amputation of the target limb. A planned or previous minor (transmetatarsal amputation or digit amputation) amputation) is permitted.
• Myocardial infarction (MI) or stroke within 90 days of the index procedure.
• Symptomatic acute heart failure New York Heart Association (NYHA) class III or greater.
• Impaired renal function (estimated Glomerular Filtration Rate (eGFR) less than or equal to 25 mL/min) within 30 days of procedure or end stage renal disease on dialysis.
• Subject with vasculitis or uncontrolled clotting disorder that may preclude patient to thrombotic events.
• Inability to tolerate dual antiplatelet and/or anticoagulation therapy, including a history of severe bleeding or coagulopathy.
• Known allergies or sensitivities to heparin, antiplatelet drugs, other anticoagulant therapies which could not be substituted, drug balloon coatings and their excipients, including, but not limited to, paclitaxel, sirolimus, or zotarolimus, or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
• The subject is currently enrolled in another investigational device or drug trial that interferes with the study endpoints.

Sponsors & Collaborators

• ReFlow Medical, Inc.: lead

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Angioplasty, Balloon, Coronary

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Angioplasty, Balloon; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques

Study Officials

• Mahmood Razavi, MD

  Providence Hospital St. Joseph

  PRINCIPAL INVESTIGATOR

• S. Jay Mathews, MD

  Manatee Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolyn Mascho, BSN, DNP, AG-NP

CONTACT

616-802-8575; cmascho@reflowmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subject will be blinded from their treatment assignment through the 12-month follow-up visit.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase A will enroll 20 subjects and evaluate 30-day safety data Phase B will enroll 345 to 518 subjects. Subjects from Phase A will be rolled into Phase B.

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 8, 2023
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 1, 2032
• Study Completion (Estimated): December 1, 2037
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share