PMCF Study for Peripheral Arteries Above the Knee (ATK)

Cordis

Status: Completed

Conditions: Femoropopliteal Stenosis; Angiopathy, Peripheral; Peripheral Arterial Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05312580

FCRE-220105_ATK

Details and patient eligibility

About

The rationale of this study is to confirm and support the clinical safety and performance of the products in a real-word population of 350 patients who underwent an endovascular intervention within standard-of-care (SOC) of the ilio-femoropopliteal artery, using at least 1 of the products (named above) from Cordis US Corp.

Enrollment: 387 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is >18 years old at conduction of the procedure.
2. Patient who underwent endovascular procedure of the ilio-femoropopliteal vessel with at least one of the following the S.M.A.R.T. Flex Stent Iliac and/or S.M.A.R.T. Flex SFA/PP and/or S.M.A.R.T. Control Nitinol Stent and/or S.M.A.R.T. Nitinol Stent and/or PALMAZ Blue .018 Peripheral Stent on Slalom and/or PALMAZ Genesis .035 Peripheral Stent on Opta Pro and/or SABER OTW PTA Catheter and/or SABERX PTA Dilatation Catheter and/or PowerFlex Pro PTA Catheter as described in the IFU of the devices.
3. Target Lesion is located in the ilio-femoropopliteal vessels.

Exclusion criteria

1. Anatomy or size of vessels that did not allow appropriate usage of the devices, following IFU of the devices.
2. Known contraindication and/or allergy to (a component of) the device as described in the IFU of the devices.
3. Women who were pregnant or lactating at the time of the procedure.
4. Life expectancy of less than 12 months at the time of procedure.
5. Any patient who was hemodynamically unstable at onset of procedure.