Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the Aspiration Catheters Family

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

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-12

Study Completion Date

2023-12-31

Brief Summary

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The purpose of this post market study is to collect clinical data of the Arthesys Aspiration catheters family during percutaneous intervention and/or stenting procedure of vessels in the central and peripheral circulation system, including saphenous vein grafts, to support MDR submission.

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Detailed Description

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Conditions

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Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients will be included as per Instructions for Use (IFU), Hospital standard of care and Good Clinical Practice (GCP):

1. Patient with a percutaneous intervention to a native coronary, saphenous vein graft, or peripheral arteries;
2. Patient with angiographic evidence of thrombus;
3. Patient \> or = 50 kg;
4. Patient \>18 years;
5. Patient who understands the trial requirements and the treatment procedures and provides written informed consent.

Exclusion Criteria

* Patients will be excluded as per IFU, Hospital standard of care and GCP, also if there are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.

Eligible Sex

ALL

Accepts Healthy Volunteers

No