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) (DEEPER REVEAL)

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).

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Critical Limb Ischemia
• Intervention / Treatment: Device: Bare Temporary Spur Stent System

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • St. Bernards Heart and Vascular
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • California
    • Orange, California, United States, 92868
      • University of California, Irvine Health
    • Orange, California, United States, 92868
      • Vascular & Interventional Specialist of Orange County
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Regional VA Medical Center
  • Connecticut
    • Darien, Connecticut, United States, 06820
      • Vascular Care Connecticut (site) / Vascular Breakthroughs (research support)
    • Shelton, Connecticut, United States, 06484
      • Southern CT Vascular Center
  • Florida
    • Boynton Beach, Florida, United States, 33436
      • Palm Beach Heart and Vascular
    • Bradenton, Florida, United States, 34205
      • Bradenton Cardiology
    • Delray Beach, Florida, United States, 33484
      • Delray Medical Center
    • Fleming Island, Florida, United States, 32003
      • First Coast Cardiovascular Institute
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
    • Ocala, Florida, United States, 34471
      • Surgical Specialists of Ocala
    • Palatka, Florida, United States, 32177
      • Ansaarie Cardiac & Endovascular Center of Excellence
    • Pensacola, Florida, United States, 32503
      • Coastal Vascular and Interventional Center
    • Winter Park, Florida, United States, 32792
      • Guardian Research
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University
    • Naperville, Illinois, United States, 60540
      • Midwest Cardiovascular Institute
  • Indiana
    • Munster, Indiana, United States, 46321
      • Community Healthcare Systems
  • Iowa
    • Bettendorf, Iowa, United States, 52722
      • UnityPoint Health Trinity Bettendorf Hospital
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Baton Rouge General Medical Center
    • Lafayette, Louisiana, United States, 70506
      • Cardiovascular Institute of the South
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Health
  • Massachusetts
    • Somerville, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Wellesley, Massachusetts, United States, 02482
      • Vascular Care Group (site) / Vascular Breakthroughs (research support)
  • Michigan
    • Grand Rapids, Michigan, United States, 49525
      • Advanced Cardiac and Vascular Centers for Amputation Prevention
    • Kalamazoo, Michigan, United States, 49048
      • Advanced Vascular Surgery
    • Roseville, Michigan, United States, 48066
      • Eastlake Cardiovascular PC
  • Missouri
    • Columbia, Missouri, United States, 65211
      • University of Missouri
    • St Louis, Missouri, United States, 63128
      • Mercy South
  • New Jersey
    • Flemington, New Jersey, United States, 08822
      • Advanced Heart and Vascular Institute of Hunterdon
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
  • North Carolina
    • Matthews, North Carolina, United States, 37232
      • Novant Health Heart & Vascular Institute
    • Murphy, North Carolina, United States, 28906
      • Sunrise Vascular
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43214
      • Ohio Health
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Lankenau Institute for Medical Research
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina (MUSC)
    • Greenville, South Carolina, United States, 29605
      • Prisma Health
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Corpus Christi, Texas, United States, 78404
      • Texas Cardiac and Vascular Institute
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • El Paso, Texas, United States, 79902
      • El Paso Cardiology Associates
    • Odessa, Texas, United States, 79430
      • Texas Tech University Health Sciences Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Pre-Procedure Inclusion Criteria:

1. 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.
2. Life expectancy greater than 1 year in the investigator's opinion.
3. Male or non-pregnant female ≥18 years of age at time of consent.
4. 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.
5. 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.

Angiographic Inclusion Criteria:

1. 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).

2. 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:

   1. Inflow lesions treated intraprocedure must be treated first, prior to consideration of treatment of infrapopliteal lesions.
   2. Treatment of in-stent restenosis in inflow treatment is permitted, provided that stents are not fractured or otherwise compromised.
   3. Distal embolic protection is strongly encouraged in cases where atherectomy is used.
   4. 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.
   5. 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.

3. 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:

   1. If the anterior tibial or posterior tibial arteries are treated, there must be inline flow to the foot.
   2. If the peroneal artery is treated, there must be at least one collateral supplying the foot.
   3. In all cases, patent runoff (no lesions with greater than 50% stenosis) must be present via the dorsalis pedis and/or plantar arteries
4. Target lesion must be located in the tibial arteries. If vessel sizing remains appropriate, treatment may extend into the distal popliteal (P3) segment.

5. Target vessel reference diameter is measured to be between 2.5 to 4.5 mm in diameter assessed by one of the following methods after successful completion of guidewire crossing of the lesion site:

   1. Intravascular Ultrasound (IVUS) (primary)
   2. Visual estimate using Angiography (secondary)
6. Target lesion length is less than or equal to 210mm in length. Tandem lesions that are less than or equal to 4 cm should be treated as one lesion. Multiple discrete lesions may be treated provided cumulative length is less than or equal to 210 mm.
7. Successful pre-dilatation of the target lesion defined as resulting in stenosis less than or equal to 50% and/or inner lumen diameter greater than or equal to 2.0 mm in diameter, without resulting flow limiting dissection, thrombus, or aneurysm by angiography prior to the insertion of the Bare Temporary Spur Stent System.

8. Only one limb and one contiguous vessel may be enrolled per subject. If required, a second modality may be used for treatment in the non-target infrapopliteal vessel.

   Note:

   1. Distal embolic protection is strongly recommended in cases using atherectomy.
   2. Treatment of the target vessel/lesion may be performed only if treatment of the non-target lesion is successful without resulting flow limiting (Type D or greater) dissection, thrombus, or aneurysm by angiography.
   3. Treatment of non-target lesions must be parallel to, and not contiguous with, the target lesion.
9. If pre-screening with duplex ultrasound, angiography, CTA, or MRA has been performed less than or equal to 365 days prior to the procedure, intra-procedure angiography of the aorto-iliac vasculature is not required, however, the femoropopliteal inflow must still be imaged using angiography during the index procedure.
10. Retrograde access (in the infrapopliteal arteries) is permitted for lesion crossing; however, the Bare Temporary Spur Stent System must be deployed from antegrade (above the knee, either ipsilateral or contralateral) access.

Pre-procedure Exclusion Criteria:

1. Subject unwilling or unlikely to comply with the 1-year duration of the study in the opinion of the investigator.
2. Subject is pregnant or planning to become pregnant during the course of the trial.
3. Subject has an active systemic infection that is not controlled at the time of the procedure, including septicemia or bacteremia.
4. Subject has osteomyelitis proximal to the phalanges. Osteomyelitis in the digit(s) of the target foot is permitted.
5. Wounds must be confined to the foot below the ankle. Heel wounds are excluded.
6. Planned major (above the ankle) amputation of the target limb. A planned or previous minor (trans metatarsal amputation or digit amputation) is permitted.
7. Recent myocardial infarction or stroke less than 90 days prior to the index procedure.
8. Symptomatic acute heart failure NYHA class III or greater.
9. Impaired renal function (eGFR less than or equal to 25 mL/min) within 30 days of procedure or end stage renal disease on dialysis.
10. Inability to tolerate dual antiplatelet and/or anticoagulation therapy.
11. 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.
12. The subject is currently enrolled in another investigational device or drug trial that interferes with the study endpoints.
13. Known allergy to nitinol or nickel.
14. Bypass surgery of the target vessel(s). Prior bypass above the level of the infrapopliteal arteries is permitted.

Angiographic Exclusion Criteria

1. 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.
2. Fractured or otherwise compromised stents in the target vessel or inflow vessel.
3. In-stent restenosis in the target vessel.
4. Previous treatment of inflow lesions performed less than or equal to 7 days prior to the index procedure.
5. Previous treatment of the target vessel less than or equal to 90 days prior to index procedure.
6. Angiographic evidence of thrombus within target limb.
7. Extremely severe calcification that, in the investigator's opinion, would not be amenable to PTA.
8. Type D dissections or greater incurred during CTO crossing (see Appendix I for definitions).
9. Significant (greater than or equal to 50%) stenosis of inflow arteries or unsuccessful treatment of inflow lesions.
10. Distance from access to lesion is too long for a 135 cm working length of the Bare Temporary Spur Stent System catheter.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bare Temporary Spur Stent System; Treatment with the Temporary Bare Spur Stent System (Spur Stent System).	Device: Bare Temporary Spur Stent System; Treatment of qualifying infrapopliteal arteries with the Bare Temporary Spur Stent System, in subjects with critical limb ischemia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ReFlow Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Actual): May 15, 2024
• Study Completion (Actual): May 23, 2025

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Peripheral Arterial Disease; Critical Limb Ischemia; Infrapopliteal Disease
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Ischemia; Pathological Conditions, Signs and Symptoms; Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease
• Other Study ID Numbers: CP-007

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