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)

ReFlow Medical, Inc.48 sites in 1 country130 target enrollmentOctober 18, 2022

ConditionsPeripheral Arterial Disease Critical Limb Ischemia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: ReFlow Medical, Inc.
Enrollment: 130
Locations: 48
Primary Endpoint: Primary Efficacy Endpoint: Percentage of Participants With Technical Success of the Bare Temporary Spur Stent
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials Related News

Overview

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).

Registry

clinicaltrials.gov

Start Date

October 18, 2022

End Date

May 23, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

ReFlow Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Angiographic Inclusion Criteria:
•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.
•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

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

Time Frame: At the end of the Index Procedure

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

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

Time Frame: 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.