Evaluating walking and pain relief in patients treated with drug-coated balloons for artery lesions
Follow-up Study in French Practice to Evaluate the Improvement of Gait and Pain Relief in Patients Treated With Endovascular Endovascular Treatment of de Novo Lesions of the Femoropopliteal Artery Above the Knee With LUTONIX®035 or RANGER TM Active Ballon
NA · Centre Hospitalier Universitaire Dijon · NCT04798352
This study is testing if two types of drug-coated balloons can help people with blocked leg arteries walk better and feel less pain.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon (other) |
| Locations | 1 site (Dijon) |
| Trial ID | NCT04798352 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the LUTONIX®035 and RANGER TM drug-coated balloon catheters in improving walking ability and relieving pain in patients with de novo lesions of the femoropopliteal artery above the knee. It involves assessing patient outcomes through a 6-minute walk test and quality of life questionnaires. The study is part of a regulatory process for the renewal of the catheters' registration in France, ensuring that patient feedback and clinical outcomes are documented and analyzed. A parallel study using SNDS data will further support the evaluation of limb preservation and overall success of the treatment.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing endovascular treatment for femoropopliteal artery lesions with the specified drug-coated balloon catheters.
Not a fit: Patients who are pregnant, unable to provide consent, or have a high likelihood of treatment failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from arterial lesions, enhancing their quality of life.
How similar studies have performed: Other studies have shown positive outcomes with similar drug-coated balloon approaches, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patient having given express oral consent * patient to be treated by endovascular procedure with a LUTONIXR035 or RANGER TM drug coated balloon catheter according to the recommendations of the ANSM dated 13/05/2019 1 and possible updates of these recommendations. Exclusion Criteria: * pregnant or likely to be pregnant (a pregnancy test may be carried out if necessary according to the centre's practice) * adult unable to express consent * patient whose follow-up is considered impossible by the investigator (comprehension problem, planned move, ...) Per-intervention exclusion criteria * patient considered to have failed endovascular treatment (presence of residual stenosis of more than 30% after surgery despite the possible use of a stent. * Patient operated on but for whom the balloon was not used during the procedure * Patient operated but for whom another balloon than those under study was finally used during the operation
Where this trial is running
Dijon
- Chu Dijon Bourgogne — Dijon, France (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Drug-coated Balloon Catheter