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Completed

NCT Number: NCT05312580

PMCF Study for Peripheral Arteries Above the Knee (ATK)

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.

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Key information

Conditions

Peripheral Arterial Disease Angiopathy, Peripheral Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Femoropopliteal Stenosis Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universität Innsbruck, Innsbruck, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Freedom from Serious Adverse Events

    Time frame: 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.

  2. Freedom from Serious Adverse Events

    Time frame: 12 months

    Primary Safety Endpoint:

    Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effect (SADEs) up to 12 months after the procedure.

  3. Technical success rate

    Time frame: 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.

  4. Freedom from clinically-driven target lesion revascularization

    Time frame: 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 outcomes

  1. Technical success rate

    Time frame: 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.

  2. Technical success rate

    Time frame: 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.

  3. Freedom from CD-TLR

    Time frame: 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.

  4. Stent fracture rate

    Time frame: 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.

  5. Stent migration rate

    Time frame: 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.

  6. Change of Ankle Brachial Index

    Time frame: 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.

  7. Time-to-hemostasis

    Time frame: 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.

  8. Time-to-ambulation

    Time frame: 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.

  9. Rate of Major Amputation free survival

    Time frame: 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.

  10. Clinical success

    Time frame: 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.

  11. Vessel perforation/dissection

    Time frame: During the procedure

    Vessel perforation/dissection during the procedure.

  12. Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs)

    Time frame: 36- and 60-months

    Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs) at 36- and 60-months after the procedure.

  13. All cause of mortality

    Time frame: procedure through study completion (12 months)

    All cause of mortality through life of the study.

Sponsors and collaborators

Lead sponsor

Cordis US Corp.

Industry

Collaborators

  • FCRE (Foundation for Cardiovascular Research and Education)

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2022
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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