A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)

NCT05358353 | Completed Results DMC FDA Device

• 1 other identifier: CP-007
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 48

Brief Summary

This is a prospective, multicenter, single arm study designed to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System).

Conditions

Peripheral Arterial Disease; Critical Limb Ischemia

Keywords

Peripheral Arterial Disease; Critical Limb Ischemia; Infrapopliteal Disease

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint: Percentage of Participants With Technical Success of the Bare Temporary Spur Stent

  Technical Success is defined as \<30% residual stenosis in subjects treated with the Bare Temporary Spur Stent System

  At the end of the Index Procedure

• Co-Primary Safety Endpoint: Percentage of Patients With no Major Adverse Limb Event (MALE) or Peri-operative Death (POD) at 30 Days Post Procedure

  Number of participants with freedom from the occurrence of major adverse limb events (MALE) \[evaluated at 30 days post procedure\] and peri-operative death (POD) \[defined as all-cause mortality within 30 days post procedure\]. MALE is defined as: * Above-the-ankle amputation of the index limb * Major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving the infrapopliteal arteries.

  30 days post procedure

Study Arms (1)

Bare Temporary Spur Stent System

EXPERIMENTAL

Treatment with the Temporary Bare Spur Stent System (Spur Stent System).

Device: Bare Temporary Spur Stent System

Interventions

Bare Temporary Spur Stent System DEVICE

Treatment of qualifying infrapopliteal arteries with the Bare Temporary Spur Stent System, in subjects with critical limb ischemia.

Bare Temporary Spur Stent System

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 witness, including a family member, sign on their behalf.
• Life expectancy greater than 1 year in the investigator's opinion.
• Male or non-pregnant female ≥18 years of age at time of consent.
• Subjects must have chronic (greater than 14 days) symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 4-5, rest pain (R 4), 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 3 days prior to the index procedure or greater than or equal to 7 days following the index procedure.
• Stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels, with target lesion that can be successfully crossed via the true lumen with a guidewire (no subintimal crossing).
• Iliac, SFA and popliteal inflow lesions can be treated using standard of care during the index procedure or greater than or equal to 3 days prior.
• 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 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 dissection, thrombus, or aneurysm by angiography.
• Target vessel(s) reconstitute(s) 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 1-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 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. Osteomyelitis in the digit(s) of the target foot is permitted.
• Wounds must be confined to the foot below the ankle. Heel wounds are excluded.
• Planned major (above the ankle) amputation of the target limb. A planned or previous minor (trans metatarsal amputation or digit amputation) is permitted.
• Recent myocardial infarction or stroke less than 90 days prior to the index procedure.
• Symptomatic acute heart failure NYHA class III or greater.
• Impaired renal function (eGFR less than or equal to 25 mL/min) within 30 days of procedure or end stage renal disease on dialysis.
• Inability to tolerate dual antiplatelet and/or anticoagulation therapy.
• Known allergies or sensitivities to heparin, antiplatelet drugs, other anticoagulant therapies which could not be substituted, 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.
• Known allergy to nitinol or nickel.
• Bypass surgery of the target vessel(s). Prior bypass above the level of the infrapopliteal arteries is permitted.
• Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion. Inflow must also be free of aneurysmal segments.

Sponsors & Collaborators

• ReFlow Medical, Inc.: lead

Study Sites (48)

St. Bernards Heart and Vascular

Jonesboro, Arkansas, 72401, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

University of California, Irvine Health

Orange, California, 92868, United States

Location

Vascular & Interventional Specialist of Orange County

Orange, California, 92868, United States

Location

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

Location

Vascular Care Connecticut (site) / Vascular Breakthroughs (research support)

Darien, Connecticut, 06820, United States

Location

Southern CT Vascular Center

Shelton, Connecticut, 06484, United States

Location

Palm Beach Heart and Vascular

Boynton Beach, Florida, 33436, United States

Location

Bradenton Cardiology

Bradenton, Florida, 34205, United States

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

First Coast Cardiovascular Institute

Fleming Island, Florida, 32003, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Surgical Specialists of Ocala

Ocala, Florida, 34471, United States

Location

Ansaarie Cardiac & Endovascular Center of Excellence

Palatka, Florida, 32177, United States

Location

Coastal Vascular and Interventional Center

Pensacola, Florida, 32503, United States

Location

Guardian Research

Winter Park, Florida, 32792, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

Midwest Cardiovascular Institute

Naperville, Illinois, 60540, United States

Location

Community Healthcare Systems

Munster, Indiana, 46321, United States

Location

UnityPoint Health Trinity Bettendorf Hospital

Bettendorf, Iowa, 52722, United States

Location

Baton Rouge General Medical Center

Baton Rouge, Louisiana, 70809, United States

Location

Cardiovascular Institute of the South

Lafayette, Louisiana, 70506, United States

Location

Ochsner Health

New Orleans, Louisiana, 70121, United States

Location

Massachusetts General Hospital

Somerville, Massachusetts, 02114, United States

Location

Vascular Care Group (site) / Vascular Breakthroughs (research support)

Wellesley, Massachusetts, 02482, United States

Location

Advanced Cardiac and Vascular Centers for Amputation Prevention

Grand Rapids, Michigan, 49525, United States

Location

Advanced Vascular Surgery

Kalamazoo, Michigan, 49048, United States

Location

Eastlake Cardiovascular PC

Roseville, Michigan, 48066, United States

Location

University of Missouri

Columbia, Missouri, 65211, United States

Location

Mercy South

St Louis, Missouri, 63128, United States

Location

Advanced Heart and Vascular Institute of Hunterdon

Flemington, New Jersey, 08822, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Novant Health Heart & Vascular Institute

Matthews, North Carolina, 37232, United States

Location

Sunrise Vascular

Murphy, North Carolina, 28906, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio Health

Columbus, Ohio, 43214, United States

Location

Lankenau Institute for Medical Research

Bryn Mawr, Pennsylvania, 19010, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac and Vascular Institute

Corpus Christi, Texas, 78404, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

El Paso Cardiology Associates

El Paso, Texas, 79902, United States

Location

Texas Tech University Health Sciences Center

Odessa, Texas, 79430, United States

Location

Sentara Norfolk General

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Carolyn Mascho
• Organization: Reflow Medical

cmascho@reflowmedical.com

949-481-0399

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: May 3, 2022
• Study Start: October 18, 2022
• Primary Completion: May 15, 2024
• Study Completion: May 23, 2025
• Last Updated: September 5, 2025
• Results First Posted: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (48)