Vessel Recoil in Specific CLTI Populations

NCT07465627 | Not Yet Recruiting

• 1 other identifier: 1469/2025
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic limb threatening ischemia (CLTI) represents the most advanced stage of peripheral arterial disease (PAD) and is characterized by ischemic rest pain, non-healing wounds, or ischemic gangrene. High-risk PAD populations including patients with end-stage renal disease and or diabetes also experience worse outcomes with significantly increased rates of amputation and mortality. Although some patients with PAD are best treated with a combination of medical management, exercise and lifestyle modification, revascularization is indicated in those with advanced stages of disease and particularly in the presence of CLTI. Revascularization of below-the-knee (BTK) arteries is required for most patients suffering from CLTI, but treatment faces numerous challenges comprising calcification, small vessel size, long-lesion length and early elastic recoil. With regard to these challenges, numerous innovative techniques and devices have been developed within the past decades to optimize endovascular treatment of BTK vessels. The Spur Peripheral Retrievable Scaffold System (Spur) was developed to directly address many of these pitfalls of infrapopliteal arterial disease. The premise of the design of the Spur is to provide temporary mechanical scaffolding and to prepare the vessel for treatment with a drug-coated balloon (DCB) to enhance drug absorption by creating channels in the endothelium by the deployed Spur. The objective of this study is to perform a prospective, single-center, single-arm, non-randomized study to evaluate acute vessel recoil following BTK treatment with the Spur Retrievable Scaffold System in combination with a commercially available DCB in specific patients populations. Specific patient populations that are selected to participate in this study are either at high risk to discover unfavorable outcomes with standard techniques due to a high complexity of lesions and/or patients that are not adequately mirrored in available studies. The patient cohorts that will be studied are diabetics and patients on hemodialysis (for at least 6 months). As women are commonly under-represented in comparable trials, this study requires at least 50% of women for each cohort. The primary endpoint is vessel recoil within 15 minutes post treatment assessed with angiography. Secondary endpoints will be followed out to 12 months.

Conditions

Chronic Limb Threatening Ischemia

Keywords

vessel recoil; peripheral arterial disease; endovascular revascularization; below-the-knee; chronic limb-threatening ischemia

Outcome Measures

Primary Outcomes (1)

• Vessel recoil assessed with angiography

  15 minutes post treatment

Secondary Outcomes (8)

• Freedom from unplanned major (above the ankle) amputation

  Up to 12 months

• Freedom from major adverse limb events (MALE)

  Up to 12 months

• Freedom from all-cause mortality

  Up to 12 months

• Freedom from clinically driven target lesion revascularisation (CD-TLR)

  Up to 12 months

• Target vessel patency determined by duplex ultrasound (DUS)

  30 days

Study Arms (2)

CLTI patients on chronic hemodialysis

Other: Vessel recoil measurement 15 minutes post final treatment (angiographically)

CLTI patients with diabetes

Other: Vessel recoil measurement 15 minutes post final treatment (angiographically)

Interventions

Vessel recoil measurement 15 minutes post final treatment (angiographically) OTHER

This study will evaluate early recoil following optimized endovascular treatment (Spur Peripheral Retrievable Scaffold System in combination with a DCB) of BTK vessels in specific high-risk patient populations with CLTI.

CLTI patients on chronic hemodialysis; CLTI patients with diabetes

Eligibility Criteria

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

Study Population

Patients with below-the knee (BTK) peripheral arterial disease (PAD) who are either with chronic kidney disease (CKD) requiring hemodialysis for at least 6 months (cohort 1) and/or diabetics (cohort 2) in Rutherford classes (RC) 4 or 5, with ≥ 50% females in each cohort

You may qualify if:

• Subject is willing and able to provide informed consent
• Subject is able to comply with the study protocol and with follow-up
• Life expectancy \>1 year in the investigator's opinion
• Subject is \> 18 years of age
• Subject must have symptoms of limb ischemia, determined by clinical symptoms of RC 4 or 5, including rest pain (RC 4) and/or minor tissue loss (RC 5), 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
• Subject has stenotic, restenotic or occlusive lesions located in BTK vessels in pre-screening with CTA, MRA or angiography prior to the index procedure.
• Subject suffers from diabetes and/or receives chronic hemodialysis for KD (for at least 6 months)
• Diabetes cohort: Subject requires for estimated glomerular filtration rate (eGFR) ≥ 25ml/min (within 30 days of procedure)
• Hemodialysis cohort: Subject has been receiving hemodialysis treatment for ≥ 6 months. (Note: subjects with diabetes who also receive chronic hemodialysis will be excluded from the diabetes cohort and will be included only in the hemodialysis cohort).
• Target lesion can be successfully crossed with a guidewire.
• Target lesion must be located in BTK arteries. Treatment of the distal popliteal segment (P3) is permitted provided that sizing remains appropriate (no more than 4.5 mm in diameter).
• Target vessel reconstitutes at or above the medial ankle, with the target treated segment extending no more than 10 mm beyond the ankle.
• 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 vessel reference diameter is measured to be between 2.5 mm to 4.5 mm in diameter.

You may not qualify if:

• Subject is unwilling or unlikely to comply with the duration of the study (up to 12 months +/-30 days post intervention) 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 and uncontrolled systemic infection, including septicemia or bacteremia
• Subject has documented active osteomyelitis proximal to the phalanges of the target limb. Osteomyelitis in the digit(s) of the target foot is permitted.
• Subject has a wound above the ankle and/or a heel wound
• Subject has planned or had previous major (above the ankle) amputation of the target limb. A planned or previous minor (transmetatarsal amputation or digit amputation) is permitted.
• Subject with poor and insufficient general condition and/or comorbidities not allowing for endovascular treatment as per the investigator's discretion
• Diabetes cohort: subject has impaired renal function as defined by an eGFR \< 25 mL/min within 30 days of procedure
• Hemodialysis cohort: subject has been receiving hemodialysis treatment for less than 6 months
• Subject with inability to comply with antiplatelet and/or anticoagulation therapy as per the facility's standard of care
• Subject with known allergies or sensitivities to heparin, antiplatelet drugs, other anticoagulant therapies which do not allow for an adequate peri- and post-procedural treatment
• Subject with known allergies or sensitivities to Paclitaxel or Sirolimus balloon coatings
• Subject with known allergies or sensitivities to contrast media that cannot be adequately pre-treated prior to the index procedure
• Subject with known allergies or sensitivities to nitinol or nickel

Sponsors & Collaborators

• Medical University of Graz: lead
• ReFlow Medical, Inc.: collaborator

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 12, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03