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

Arthesys

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05536167

ART-ASPI CATHETER-01

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Volunteers: No Healthy Volunteers

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.