PMCF Study for Peripheral Arteries Above the Knee (ATK)

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Femoropopliteal Stenosis; Angiopathy, Peripheral

• Study Type: Observational
• Enrollment (Actual): 387

Contacts and Locations

• Study Contact: Name: Lema Vadder; Phone Number: +4915780632765; Email: lena.vadder@fcre.eu

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Medizinische Universität Innsbruck
  • Klagenfurt am Wörthersee, Austria, 9020
    • KABEG-Klinikum Klagenfurt am Wörthersee
  • St.Pölten, Austria, 3100
    • Universitätsklinikum St. Pölten - Lilienfeld
  • Wien, Austria, 1090
    • Medizinische Universität WienMedizinische Universität Wien
• France
  • Arras, France, 31059
    • Public health establishment, Arras Hospital
  • Marseille, France, 13354
    • Hôspital de la Timone
  • Toulouse, France, 31059
    • The Public Hospital, Centre Hospitalier Universitaire de Toulouse
  • Toulouse, France, 31300
    • Clinique River Gauche
• Netherlands
  • Leiden, Netherlands, 2333
    • Leiden University Medical Center (LUMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from Serious Adverse Events	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.	30 days
Freedom from Serious Adverse Events	Primary Safety Endpoint: Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effect (SADEs) up to 12 months after the procedure.	12 months
Technical success rate	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.	During the procedure
Freedom from clinically-driven target lesion revascularization	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	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.	During the procedure
Technical success rate	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.	Day of procedure
Freedom from CD-TLR	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.	36- and 60-months
Stent fracture rate	Stent fracture rate assessed at up to 30 days post-procedure, 12-, 36- and 60-months.	Up to 30 days post-procedure, 12-, 36- and 60-months
Stent migration rate	Stent migration rate assessed at up to 30 days post-procedure, 12-, 36- and 60-months.	Up to 30 days post-procedure, 12-, 36- and 60-months
Change of Ankle Brachial Index	Change of Ankle Brachial Index (ABI) assessed at up to 30 days post-procedure, 12-, 36- and 60-months compared to baseline ABI.	Up to 30 days post-procedure, 12-, 36- and 60-months
Time-to-hemostasis	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.	Day of procedure
Time-to-ambulation	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.	Day of procedure
Rate of Major Amputation free survival	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.	Up to 30 days post-procedure, 12-, 36- and 60-months
Clinical success	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.	Up to 30 days post-procedure, 12-, 36- and 60-months
Vessel perforation/dissection	Vessel perforation/dissection during the procedure.	During the procedure
Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs)	Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs) at 36- and 60-months after the procedure.	36- and 60-months
All cause of mortality	All cause of mortality through life of the study.	procedure through study completion (12 months)

Collaborators and Investigators

• Sponsor: Cordis Corporation
• Collaborators: FCRE (Foundation for Cardiovascular Research and Education)

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): October 7, 2022
• Study Completion (Actual): November 7, 2022

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: FCRE-220105_ATK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No