Status:
COMPLETED
PMCF Study for Peripheral Arteries Above the Knee (ATK)
Lead Sponsor:
Cordis US Corp.
Collaborating Sponsors:
FCRE (Foundation for Cardiovascular Research and Education)
Conditions:
Peripheral Arterial Disease
Femoropopliteal Stenosis
Eligibility:
All Genders
18+ years
Brief 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 st...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 7 2022
Estimated Enrollment :
387 Patients enrolled
Trial Details
Trial ID
NCT05312580
Start Date
June 1 2022
End Date
November 7 2022
Last Update
July 27 2023
Active Locations (9)
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1
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
2
KABEG-Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria, 9020
3
Universitätsklinikum St. Pölten - Lilienfeld
Sankt Pölten, Austria, 3100
4
Medizinische Universität WienMedizinische Universität Wien
Vienna, Austria, 1090