CompletedNot Applicable

PMCF Study for Peripheral Arteries Below the Knee (BTK)

Austria, Germany102 participantsStarted 2022-05-05

Plain-language summary

The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-word population of 100 patients who underwent an endovascular intervention within standard-of-care (SOC) of the infra-popliteal vessels, using at least one of the products (named above) from Cordis US Corp.

Who can participate

Age range18 Years

SexALL

See this in plain English?

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.
✓. Target Lesion is located in the infrapopliteal arteries.
✓. Patient who underwent treatment (PTA) in the infrapopliteal vessels with at least one of the SABER OTW PTA Catheter the SABERX PTA Catheter and/or the Powerflex Pro PTA Catheter as described in the IFU for each device.

Exclusion criteria

✕. Anatomy or size of vessels that would have not allowed appropriate usage of the study devices, following IFU of the study devices.
✕. Patients who were not suitable for receiving interventional surgeries of lower limb arteries for treatment.
✕. Women who were pregnant or lactating at time of the procedure.
✕. Any patient who was considered to be hemodynamically unstable at onset of procedure.
✕. Patient was not available for follow up at the clinical site.

What they're measuring

Number of Patients without Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs

Timeframe: 30 days post procedure

Number of Patients without Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs

Timeframe: 30 days post procedure

Technical success rate

Timeframe: during surgery

Number of Participants without Freedom from clinically-driven target lesion revascularization (CD-TLR)

Timeframe: 30 days post procedure

Trial details

NCT IDNCT05444660

SponsorCordis US Corp.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-09-09

View on ClinicalTrials.gov More Peripheral Artery Disease trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

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.
✓. Target Lesion is located in the infrapopliteal arteries.
✓. Patient who underwent treatment (PTA) in the infrapopliteal vessels with at least one of the SABER OTW PTA Catheter the SABERX PTA Catheter and/or the Powerflex Pro PTA Catheter as described in the IFU for each device.

Exclusion criteria

✕. Anatomy or size of vessels that would have not allowed appropriate usage of the study devices, following IFU of the study devices.
✕. Patients who were not suitable for receiving interventional surgeries of lower limb arteries for treatment.
✕. Women who were pregnant or lactating at time of the procedure.
✕. Any patient who was considered to be hemodynamically unstable at onset of procedure.
✕. Patient was not available for follow up at the clinical site.

What they're measuring

Number of Patients without Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs

Timeframe: 30 days post procedure

Number of Patients without Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs

Timeframe: 30 days post procedure

Technical success rate

Timeframe: during surgery

Number of Participants without Freedom from clinically-driven target lesion revascularization (CD-TLR)

Timeframe: 30 days post procedure