Status:
UNKNOWN
Efficacy of Rotational Atherectomy System Associated With Drug Coated Balloon Angioplasty in Limb Ischemia
Lead Sponsor:
Hospital St. Joseph, Marseille, France
Conditions:
Peripheral Vascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Lower extremity peripheral artery disease (PAD) is a major health problem leading to significant morbidity and even mortality. Patients with superficial femoral artery stenosis make up an important pr...
Eligibility Criteria
Inclusion
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Diagnosed with moderate to severe claudication: chronic symptomatic AOMI (Rutherford 2 and 3)
- Diagnosed with de novo obstructive lesions calcified in the superficial femoral artery or in P1: tight stenosis (\> 70%), calcified, layered, length ˃ 10 cm or short calcified occlusions \<5 cm from the superior femoral artery and P1.
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
- Affiliated to social safety plan of beneficiary under such a plan
Exclusion
- Intra stent re-stenosis
- Recent occlusions, less than 1 month old of SFA and / or P1 (probable thrombus)
- SFA occlusion, P1 \> 5 cm, from origin of SFA.
- SFA stenosis \<10 cm
- Non calcified stenosis
- Participants who have participated in another research study involving an investigational product in the past 12 weeks
- Participant issuing with a safeguard measure of justice (in accordance with the low article L1122-2 of the public health code)
Key Trial Info
Start Date :
March 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04276311
Start Date
March 4 2020
End Date
December 30 2024
Last Update
May 12 2022
Active Locations (8)
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1
Hopital Prive de Provence
Aix-en-Provence, France, 13595
2
Clinique Rhône Durance
Avignon, France, 84000
3
Polyclinique Notre Dame
Draguignan, France, 83300
4
Hopital Europeen
Marseille, France, 13000