CompletedNot Applicable

PMCF Study for Peripheral Arteries Above the Knee (ATK)

Austria, France387 participantsStarted 2022-06-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patient is \>18 years old at conduction of the procedure.
✓. 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.
✓. Target Lesion is located in the ilio-femoropopliteal vessels.

Exclusion criteria

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

What they're measuring

Freedom from Serious Adverse Events

Timeframe: 30 days

Freedom from Serious Adverse Events

Timeframe: 12 months

Technical success rate

Timeframe: During the procedure

Freedom from clinically-driven target lesion revascularization

Timeframe: 12 months

Trial details

NCT IDNCT05312580

SponsorCordis US Corp.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-10-07

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