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Resoloy Initial Safety Evaluation

NCT07648017 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-06-15

No results posted yet for this study

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)

Interventions

DEVICE

PTA

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

Sponsors & Collaborators

  • MeKo Manufacturing e.K.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-23
Primary Completion
2026-12-01
Completion
2027-12-01

Countries

  • Uzbekistan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07648017 on ClinicalTrials.gov