A Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base DCB

NCT04162418 | Completed DMC

• 1 other identifier: CP-005
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-randomized, prospective, single center pilot study designed to evaluate the safety of the Temporary Spur Stent System to treat patients with infrapopliteal arterial disease, when used in conjunction with a commercially available limus-base drug coated balloon.

Conditions

Peripheral Arterial Disease; Critical Limb Ischemia

Keywords

peripheral arterial disease; critical limb ischemia; infrapopliteal disease

Outcome Measures

Primary Outcomes (1)

• Rate of All-Cause Mortality, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR) at 6 months

  6 month composite of All-Cause Mortality, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR)

  6 months

Secondary Outcomes (4)

• Secondary Efficacy: Late lumen loss

  6 months

• Secondary Efficacy: Primary Patency

  6 months

• Secondary Efficacy: Rutherford class

  12 months

• Secpndary Efficacy: Wound healing

  12 months

Other Outcomes (2)

• Secondary Safety: 30 days

  30 days

• Secondary Safety: 6 and 12 months

  12 months

Study Arms (1)

Intervention

OTHER

Treatment with Temporary Spur Stent System and a commercially available, limus-base, drug coated balloon

Device: Temporary Spur Stent System

Interventions

Temporary Spur Stent System DEVICE

Treatment of qualifying infrapopliteal lesions with Temporary Spur Stent System and a commercially available, limus-base drug-coated balloon

Intervention

Eligibility Criteria

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

You may qualify if:

• Subject is willing and able to provide informed consent and able to comply with the study protocol.
• Life expectancy \>1 year in the investigator's opinion.
• Subject is \> 18 years of age.
• Subjects must have symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 3-5, including severe, life-limiting claudication (R 3), 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
• Stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels, with target lesion that can be successfully crossed with a guidewire.
• Target lesion must meet lesion-specific criteria in pre-screening by angiography at time of procedure (prescreening with CTA, MRA or selective angiography may be performed prior to the index procedure).
• Target vessel(s) reconstitute(s) at or above the ankle, with the target treated segment extending no more than 10 mm beyond the ankle.
• Note:
• If the anterior tibial or posterior tibial arteries are treated, there must be inline flow to the foot.
• If the peroneal artery is treated, there must be at least one collateral supplying the foot.
• Target lesion must begin no higher than the tibial trifurcation (popliteal artery excluded).
• Target vessel reference diameter is measured to be between 2.0 mm to 4.5 mm in diameter, assessed by one of the following methods after successful completion of guidewire crossing of the lesion site:
• Intravascular Ultrasound (IVUS)
• Optical Coherence Tomography (OCT)
• Quantitative Vascular Angiography (QVA)

You may not qualify if:

• Subject unwilling or unlikely to comply with the appropriate follow up time for the 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 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.
• Subject has a heel wound, unless osteomyelitis has been ruled out with MRI, MRA, or nuclear medicine bone scan
• Planned major (above the ankle) amputation of the target limb. A planned or previous minor (transmetatarsal amputation or digit amputation) is permitted
• Recent myocardial infarction or stroke \< 90 days prior to the index procedure.
• Symptomatic acute heart failure NYHA class III or greater.
• Impaired renal function (eGFR \<25 mL/min) within 30 days of procedure or end stage renal disease on dialysis
• Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica.
• Subject receiving chronic or intravenous corticosteroid therapy.
• 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, 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.
• Known allergy to nitinol or nickel.

Sponsors & Collaborators

• ReFlow Medical, Inc.: lead

Study Sites (1)

Univ.-Klinikum LKH Graz

Graz, 8036, Austria

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

Study Officials

• Marianne Brodmann, MD

  Univ-Klinikum LKH Graz

  PRINCIPAL INVESTIGATOR

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: November 11, 2019
• First Posted: November 14, 2019
• Study Start: February 14, 2020
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)