CLTI Defined as Rutherford Category 4 or 5RISENCT07648017
Resoloy Initial Safety Evaluation
A study testing PTA in people with CLTI Defined as Rutherford Category 4 or 5 and PAOD (Peripheral Arterial Obstructive Disease), run by MeKo Manufacturing e.K. at 1 site in Uzbekistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLTI Defined as Rutherford Category 4 or 5, PAOD (Peripheral Arterial Obstructive Disease)
- What is being tested?
- PTA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUzbekistan
- Study dates
- 23 Aug 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
- Pregnant females or females of child-bearing potential without negative result of pregnancy test
- Lesion related
- In-stent restenosis (metallic stent)
- Severe calcification (calcification renders the target lesion non-dilatable or has ≥5 cm of circumferential calcification)
- Evidence of thrombus in target vessel
- Evidence of thromboembolism or atheroembolism in the study leg
- No angiographic evidence of a patent pedal artery
- Aneurysm at treatment location
- Lesions/dissections exceeding 27 mm
- Visual hint of an additional significant stenosis (≥50%) in the target vessel prior index procedure
Trial locations and contacts
1 site in 1 country.
Uzbekistan1 site
Republican Specialized Scientific and Practical Medical Center of Therapy and Medical Rehabilitation (clinical base "Nano Medical Clinic" at "GARBUS TRADE" JV LLC)
Tashkent, 100095
About this study
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)
- Being tested
- PTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTADevice
Following the verification of all inclusion and exclusion criteria, the BioFade scaffold is delivered to the treatment site and will be deployed.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: PTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety endpoint
Freedom from device and procedure related events (thrombosis, embolization, amputation, device-related death, target lesion reintervention) at 30 days
Measured: day 30
Secondary outcomes (4)
Efficacy endpoint
Device success
Measured: day 1
Efficacy endpoint
Procedural success
Measured: day 1
Efficacy endpoint
CD-TLR
Measured: year 1
Efficacy endpoint
MALE
Measured: year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start23 Aug 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLTI Defined as Rutherford Category 4 or 5Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- MeKo Manufacturing e.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648017
- Sponsor's protocol ID
- RISE-01
- Other IDs
- No 8/3-2143
- Acronym
- RISE
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resoloy Initial Safety Evaluation
- ClinicalTrials.gov ID
- NCT07648017
- Acronym / sponsor ID
- RISE / RISE-01
- Conditions
- CLTI Defined as Rutherford Category 4 or 5, PAOD (Peripheral Arterial Obstructive Disease)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- MeKo Manufacturing e.K.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: PTA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTAFollowing the verification of all inclusion and exclusion criteria, the BioFade scaffold is delivered to the treatment site and will be deployed. | Device | A |
Primary outcome
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
4 secondary outcomes
Efficacy endpoint
Time frame: day 1
Efficacy endpoint
Time frame: day 1
Efficacy endpoint
Time frame: year 1
Efficacy endpoint
Time frame: year 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTA in people with CLTI Defined as Rutherford Category 4 or 5 and PAOD (Peripheral Arterial Obstructive Disease), run by MeKo Manufacturing e.K. at 1 site in Uzbekistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety endpoint (time frame: day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.