Resoloy Initial Safety Evaluation (RISE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: PAOD (Peripheral Arterial Obstructive Disease); CLTI Defined as Rutherford Category 4 or 5
• Intervention / Treatment: Device: PTA

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uzbekistan
  • Tashkent, Uzbekistan, 100095
    • Republican Specialized Scientific and Practical Medical Center of Therapy and Medical Rehabilitation (clinical base "Nano Medical Clinic" at "GARBUS TRADE" JV LLC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

Patient related

1. Subject at least 18 years of age and provided written informed consent
2. RF class 3, 4 or 5
3. Subject requires treatment of up to 2 de novo or non-ISR restenotic lesions in BTK arteries
4. Female subjects of childbearing potential must have a negative pregnancy test prior to treatment

5. Presence of at least one patent (<50% DS) infrapopliteal vessel that has not been revascularized prior to index procedure

   Lesion related

6. Presence of elastic recoil or dissection type C-F requiring mechanical support after balloon angioplasty (diameter stenosis >30% by visual estimate)
7. Lesion must be located in the native infrapopliteal vessels with reference vessel diameter of ≥2.5 and 4 mm (investigators assessment)
8. Total lesion length/vessel length covered by BioFade scaffold should not exceed 27 mm
9. 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.
10. Distal margin of lesion must be located ≥10 cm above the proximal margin of the ankle mortise
11. Non-target lesion, if any, must be located in separate infrapopliteal arteries and suitable to be treated per standard of care using PTA

Exclusion Criteria:

Patient related

1. Prior amputation to the ipsilateral extremity other than the toe or forefoot or major amputation to the contralateral extremity <1 year prior index procedure
2. Subject has known hypersensitivity or contraindication to device material and its degradants (that cannot be adequately premedicated)
3. Subject has known allergic reaction, hypersensitivity or contraindication to aspirin, clopidogrel/prasugrel/ticagrelor and anti-coagulants
4. Subject has known hypersensitivity or allergy to contrast media that cannon be medically managed
5. Planned amputation on target leg other than toe or forefoot
6. Systemic infection or infection within the target limb and/or immunocompromised
7. Endovascular or surgical procedure on the target limb within 30 days prior index procedure (not including diagnostic procedures)
8. Myocardial infarction within 30 days prior enrollment
9. History of stroke within 90 days prior enrollment
10. Patient is currently participating in another clinical study whose requirements conflict with or affect this clinical investigation
11. 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
12. Patient has subacute limb ischemia which requires thrombolysis as a treatment modality
13. Patient has acute limb ischemia of the target limb
14. Patient is bedridden or unable to walk (assistance is acceptable)

15. Pregnant females or females of child-bearing potential without negative result of pregnancy test

    Lesion related

16. In-stent restenosis (metallic stent)
17. Severe calcification (calcification renders the target lesion non-dilatable or has ≥5 cm of circumferential calcification)
18. Evidence of thrombus in target vessel
19. Evidence of thromboembolism or atheroembolism in the study leg
20. No angiographic evidence of a patent pedal artery
21. Aneurysm at treatment location
22. Lesions/dissections exceeding 27 mm
23. Visual hint of an additional significant stenosis (≥50%) in the target vessel prior index procedure

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety endpoint	Freedom from device and procedure related events (thrombosis, embolization, amputation, device-related death, target lesion reintervention) at 30 days	day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy endpoint	Device success	day 1
Efficacy endpoint	Procedural success	day 1
Efficacy endpoint	CD-TLR	year 1
Efficacy endpoint	MALE	year 1

Collaborators and Investigators

• Sponsor: MeKo Manufacturing e.K.

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RISE-01; No 8/3-2143 (Other Identifier: Ministry of Health of Republic of Uzbekistan / Ethical Committee)

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: No