Resoloy Initial Safety Evaluation (RISE)

June 9, 2026 updated by: MeKo Manufacturing e.K.

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
safety endpoint
Time Frame: day 30
Freedom from device and procedure related events (thrombosis, embolization, amputation, device-related death, target lesion reintervention) at 30 days
day 30

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy endpoint
Time Frame: day 1
Device success
day 1
Efficacy endpoint
Time Frame: day 1
Procedural success
day 1
Efficacy endpoint
Time Frame: year 1
CD-TLR
year 1
Efficacy endpoint
Time Frame: year 1
MALE
year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MeKo Manufacturing e.K.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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