Endovascular Treatment of Primary Common FEmoral Artery atheroSclerotic Disease wiTh IntraVAscular Litothripsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-05-01

Brief Summary

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Prospective, nonrandomized, multicenter, national, multidisciplinary, real-world data collection with the aim to evaluate the short-term safety and efficacy of intravascular lithotripsy in the treatment of steno-obstructive disease of the common femoral artery

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Detailed Description

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Conditions

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Peripheral Arterial Disease Common Femoral Artery Stenosis Common Femoral Artery Occlusion Critical Limb-Threatening Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Intravascular litothripsy (IVL)

endovascular treatment of primary common femoral artery atherosclerotic disease with intravascular litothripsy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients with peripheral arterial disease (Rutherford class 3-6)
2. Presence of a steno-obstructive lesion of the common femoral artery (Azema classification 1-3)
3. Possible endovascular treatment of both the iliac axis and/or femoro-distal vessels
4. Possible post-dilatation with plain or drug-coated balloon angioplasty

Exclusion Criteria

1. Concomitant open surgery (ilio-femoral or femoro-distal bypass)
2. Presence of a steno-obstructive lesion of the common femoral artery in previous open surgery (Azema classification 4)
3. Presence of a steno-obstructive lesion of the common femoral artery after a previous endovascular procedure

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No