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Active Not Recruiting NCT07648017

Resoloy Initial Safety Evaluation

Conditions: CLTI Defined as Rutherford Category 4 or 5, PAOD (Peripheral Arterial Obstructive Disease)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: MeKo Manufacturing e.K.

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

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.

Eligibility Criteria

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 (\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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07648017). StuddyBuddy aggregates publicly available trial information.