PMCF Study for Peripheral Arteries Above the Knee (ATK)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Freedom from Serious Adverse Events [30 days]
Acute primary Safety Endpoint: Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effect (SADEs) during the procedure and up to 30 days after the procedure.
- Freedom from Serious Adverse Events [12 months]
Primary Safety Endpoint: Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effect (SADEs) up to 12 months after the procedure.
- Technical success rate [During the procedure]
Acute Primary Efficacy Endpoint: Technical success rate defined as successful crossing, introduction, deployment (stents)/deflation (balloon catheter) and a <30% residual stenosis on visual assessment of 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 according to the respective IFU.
- Freedom from clinically-driven target lesion revascularization [12 months]
Primary Efficacy Endpoint: The primary efficacy endpoint is freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as any reintervention at the target lesion due to symptoms.
Secondary Outcome Measures
- Technical success rate [During the procedure]
Technical success rate defined as successful crossing, introduction, deployment and successful completion of the procedure of the Cordis guidewires (Emerald, ATW, Stablizer, Storq, SV 0.018", Wizdom) and/or the Cordis guiding catheters (Adroit, Vista Brite Tip) and/or the Cordis diagnostic catheters (Super Torque, Super Torque MB, Super Torque Plus, Infiniti 4F/5F/6F, Tempo 4F, Tempo Aqua, High Flow, Pigtail Straightener) and/or the Cordis vascular access devices (Avanti+, Brite Tip, Vista Brite IG, vessel dilator) and/or the Cordis vascular closure devices (MynxGrip and Mynx Control) and/or the Cordis OUTBACK CTO catheters according to the respective IFU.
- Technical success rate [Day of procedure]
Technical success rate defined as successful hemostasis without conversion to manual/mechanical compression of the Cordis vascular closure devices (MynxGrip and Mynx Control) according to the respective IFU.
- Freedom from CD-TLR [36- and 60-months]
Freedom from clinically-driven target lesion revascularization (CD-TLR) at 36- and 60-months, defined as any reintervention at the target lesion due to symptoms.
- Stent fracture rate [Up to 30 days post-procedure, 12-, 36- and 60-months]
Stent fracture rate assessed at up to 30 days post-procedure, 12-, 36- and 60-months.
- Stent migration rate [Up to 30 days post-procedure, 12-, 36- and 60-months]
Stent migration rate assessed at up to 30 days post-procedure, 12-, 36- and 60-months.
- Change of Ankle Brachial Index [Up to 30 days post-procedure, 12-, 36- and 60-months]
Change of Ankle Brachial Index (ABI) assessed at up to 30 days post-procedure, 12-, 36- and 60-months compared to baseline ABI.
- Time-to-hemostasis [Day of procedure]
Time-to-hemostasis assessed for the Cordis vascular closure devices (MynxGrip and Mynx Control). Categorized as Hemostatic time category (HTC) ≤2, HTC >2 to ≤4, HTC >4 to ≤5, HTC >5 to ≤7, HTC >7 to ≤10 min.
- Time-to-ambulation [Day of procedure]
Time-to-ambulation assessed for the Cordis vascular closure devices (MynxGrip and Mynx Control) defined as time between end of the procedure and ambulation in hours.
- Rate of Major Amputation free survival [Up to 30 days post-procedure, 12-, 36- and 60-months]
Rate of Major Amputation free survival defined as any amputation above the knee assessed at up to 30 days post-procedure, 12-, 36- and 60-months.
- Clinical success [Up to 30 days post-procedure, 12-, 36- and 60-months]
Clinical success at up to 30 days post procedure, 12-, 36- and 60-months, defined as an improvement of the Rutherford Classification of one class or more, as compared to the pre-procedure Rutherford Classification.
- Vessel perforation/dissection [During the procedure]
Vessel perforation/dissection during the procedure.
- Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs) [36- and 60-months]
Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs) at 36- and 60-months after the procedure.
- All cause of mortality [procedure through study completion (12 months)]
All cause of mortality through life of the study.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is >18 years old at conduction of the procedure.
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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.
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Target Lesion is located in the ilio-femoropopliteal vessels.
Exclusion Criteria:
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Anatomy or size of vessels that did not allow appropriate usage of the devices, following IFU of the devices.
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Known contraindication and/or allergy to (a component of) the device as described in the IFU of the devices.
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Women who were pregnant or lactating at the time of the procedure.
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Life expectancy of less than 12 months at the time of procedure.
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Any patient who was hemodynamically unstable at onset of procedure.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | KABEG-Klinikum Klagenfurt am Wörthersee | Klagenfurt am Wörthersee | Austria | 9020 |
Sponsors and Collaborators
- Cordis Corporation
- FCRE (Foundation for Cardiovascular Research and Education)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FCRE-220105_ATK