Clinical trial NCT05312580: PMCF Study for Peripheral Arteries Above the Knee (ATK)
Official title: A Retrospective PMCF Study Evaluating the Safety and Clinical Performance of the S.M.A.R.T. Flex Stent Iliac, S.M.A.R.T. Flex SFA/PP, S.M.A.R.T. Control Nitinol Stent, S.M.A.R.T. Nitinol Stent, PALMAZ Blue .018 Peripheral Stent on Slalom, PALMAZ Genesis .035 Peripheral Stent on Opta Pro, SABER OTW PTA Catheter, SABERX PTA Dilatation Catheter and PowerFlex Pro PTA Catheter for the Endovascular Interventions in the Ilio-femoropopliteal Vessels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Femoropopliteal Stenosis
Angiopathy, Peripheral
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
Collaborators: name: FCRE (Foundation for Cardiovascular Research and Education)
First posted: 2022-04-05
Enrollment: 387
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who underwent endovascular procedure of the ilio-femoropopliteal vessel with at least one of the above mentioned study devices.

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 standard-of-care (SOC) of the ilio-femoropopliteal artery, using at least 1 of the products (named above) from Cordis US Corp.


Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from Serious Adverse Events
timeFrame: 30 days
measure: Freedom from Serious Adverse Events
timeFrame: 12 months
measure: Technical success rate
timeFrame: During the procedure
measure: Freedom from clinically-driven target lesion revascularization
timeFrame: 12 months
Secondary outcomes:
measure: Technical success rate
timeFrame: During the procedure
measure: Technical success rate
timeFrame: Day of procedure
measure: Freedom from CD-TLR
timeFrame: 36- and 60-months
measure: Stent fracture rate
timeFrame: Up to 30 days post-procedure, 12-, 36- and 60-months
measure: Stent migration rate
timeFrame: Up to 30 days post-procedure, 12-, 36- and 60-months
measure: Change of Ankle Brachial Index
timeFrame: Up to 30 days post-procedure, 12-, 36- and 60-months
measure: Time-to-hemostasis
timeFrame: Day of procedure
measure: Time-to-ambulation
timeFrame: Day of procedure
measure: Rate of Major Amputation free survival
timeFrame: Up to 30 days post-procedure, 12-, 36- and 60-months
measure: Clinical success
timeFrame: Up to 30 days post-procedure, 12-, 36- and 60-months
measure: Vessel perforation/dissection
timeFrame: During the procedure
measure: Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs)
timeFrame: 36- and 60-months
measure: All cause of mortality
timeFrame: procedure through study completion (12 months)
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Klagenfurt am Wörthersee
country: Austria
facility: KABEG-Klinikum Klagenfurt am Wörthersee
city: St.Pölten
country: Austria
facility: Universitätsklinikum St. Pölten - Lilienfeld
city: Wien
country: Austria
facility: Medizinische Universität WienMedizinische Universität Wien
city: Arras
country: France
facility: Public health establishment, Arras Hospital
city: Marseille
country: France
facility: Hospital de la Timone
city: Toulouse
country: France
facility: The Public Hospital, Centre Hospitalier Universitaire de Toulouse
city: Toulouse
country: France
facility: Clinique River Gauche
city: Leiden
country: Netherlands
facility: Leiden University Medical Center (LUMC)
Study officials:
References: