Resoloy Initial Safety Evaluation

NCT07648017 | Active Not Recruiting

• 2 other identifiers: RISE-01No 8/3-2143
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to learn if the resorbable scaffold can be successfully implanted in below-the-knee arteries and help to restore the blood flow in diseased vessels. The main questions which will be addressed in this study are:

• Is the implantation of the scaffold safe and easy?
• Does the scaffold dissolve in a reasonable time period?
• Can the stent help to fix intervention-derived vessel injuries such as dissection or recoil? The scaffold will be implanted in patients with critical limb-threatening ischemia which were initially treated with balloon catheters to restore blood flow and where a vessel segment needs additional stabilisation. The scaffold will be implanted during the normal interventional procedure. All 10 patients enrolled into this study will receive at least one scaffold. There is no control group. The patients will be monitored for their wellbeing after 30 days as well as after 6 and 12 months. The status of the treated vessels will be examined using a non-invasive ultrasound method.

Conditions

CLTI Defined as Rutherford Category 4 or 5; PAOD (Peripheral Arterial Obstructive Disease)

Outcome Measures

Primary Outcomes (1)

• safety endpoint

  Freedom from device and procedure related events (thrombosis, embolization, amputation, device-related death, target lesion reintervention) at 30 days

  day 30

Secondary Outcomes (4)

• Efficacy endpoint

  day 1

• Efficacy endpoint

  day 1

• Efficacy endpoint

  year 1

• Efficacy endpoint

  year 1

Study Arms (1)

A

EXPERIMENTAL

Device: PTA

Interventions

PTA DEVICE

Following the verification of all inclusion and exclusion criteria, the BioFade scaffold is delivered to the treatment site and will be deployed.

A

Eligibility Criteria

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

You may qualify if:

• Patient related
• Subject at least 18 years of age and provided written informed consent
• RF class 3, 4 or 5
• Subject requires treatment of up to 2 de novo or non-ISR restenotic lesions in BTK arteries
• Female subjects of childbearing potential must have a negative pregnancy test prior to treatment
• Presence of at least one patent (\<50% DS) infrapopliteal vessel that has not been revascularized prior to index procedure
• Lesion related
• Presence of elastic recoil or dissection type C-F requiring mechanical support after balloon angioplasty (diameter stenosis \>30% by visual estimate)
• Lesion must be located in the native infrapopliteal vessels with reference vessel diameter of ≥2.5 and 4 mm (investigators assessment)
• Total lesion length/vessel length covered by BioFade scaffold should not exceed 27 mm
• Significant lesion (≥ 50% stenosis) in the inflow artery(ies) must be treated successfully (as per physician's assessment) through standard of care prior to the treatment of the target lesion. Treatment can be done within the same trial procedure.
• Distal margin of lesion must be located ≥10 cm above the proximal margin of the ankle mortise
• Non-target lesion, if any, must be located in separate infrapopliteal arteries and suitable to be treated per standard of care using PTA

You may not qualify if:

• Patient related
• Prior amputation to the ipsilateral extremity other than the toe or forefoot or major amputation to the contralateral extremity \<1 year prior index procedure
• Subject has known hypersensitivity or contraindication to device material and its degradants (that cannot be adequately premedicated)
• Subject has known allergic reaction, hypersensitivity or contraindication to aspirin, clopidogrel/prasugrel/ticagrelor and anti-coagulants
• Subject has known hypersensitivity or allergy to contrast media that cannon be medically managed
• Planned amputation on target leg other than toe or forefoot
• Systemic infection or infection within the target limb and/or immunocompromised
• Endovascular or surgical procedure on the target limb within 30 days prior index procedure (not including diagnostic procedures)
• Myocardial infarction within 30 days prior enrollment
• History of stroke within 90 days prior enrollment
• Patient is currently participating in another clinical study whose requirements conflict with or affect this clinical investigation
• Presence of any conditions that, in the investigator's opinion, could limit the participants ability to comply with the follow-up requirements, or impact the scientific soundness of the clinical investigation results
• Patient has subacute limb ischemia which requires thrombolysis as a treatment modality
• Patient has acute limb ischemia of the target limb
• Patient is bedridden or unable to walk (assistance is acceptable)

Sponsors & Collaborators

• MeKo Manufacturing e.K.: lead

Study Sites (1)

Republican Specialized Scientific and Practical Medical Center of Therapy and Medical Rehabilitation (clinical base "Nano Medical Clinic" at "GARBUS TRADE" JV LLC)

Tashkent, 100095, Uzbekistan

Location

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: May 8, 2026
• First Posted: June 15, 2026
• Study Start: August 23, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)