ACHIEVE GRX Registry

Corindus

Status: Withdrawn

Conditions: Renal Artery Disease; Peripheral Vascular Diseases; Peripheral Arterial Disease; Carotid Artery Diseases

Treatments: Device: Procedure/Surgery: Robotic-PVI

Study type: Observational

Funder types: Industry

Identifiers

NCT04513613

104-09200

Details and patient eligibility

About

This study will evaluate real-world performance of the CorPath GRX System in peripheral vascular interventions.

Full description

This is a prospective, single-arm, open-label, multi-center registry of the CorPath GRX System to evaluate its real-world performance during peripheral vascular interventions.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years.
2. Subject has a clinical indication for Peripheral Vascular Intervention (PVI).
3. Subject is deemed appropriate for robotic-assisted PVI.
4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
5. Individual monitoring of radiation dose, using the pocket dosimeter, was initiated at start of procedure.

Exclusion criteria

1. Failure/inability/unwillingness to provide informed consent.
2. The investigator determines the subject or the peripheral anatomy is not suitable for ro-botic-assisted PVI.
3. Women who are pregnant.

Trial design

0 participants in 1 patient group

Subjects with a clinical indication for PVI

Description:

Subjects with a clinical indication for Peripheral Vascular Intervention (PVI).

Treatment:

Device: Procedure/Surgery: Robotic-PVI