PMCF Study for Peripheral Arteries Above the Knee (ATK)

Cordis US Corp.387 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

387

Conditions

Peripheral Arterial Disease Femoropopliteal Stenosis Angiopathy, Peripheral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

Medizinische Universität Innsbruck

Innsbruck, Austria

KABEG-Klinikum Klagenfurt am Wörthersee

Klagenfurt, Austria

Universitätsklinikum St. Pölten - Lilienfeld

Sankt Pölten, Austria

Medizinische Universität WienMedizinische Universität Wien

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12 months

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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Public health establishment, Arras Hospital

Arras, France

Hospital de la Timone

Marseille, France

The Public Hospital, Centre Hospitalier Universitaire de Toulouse

Toulouse, France

Clinique River Gauche

Toulouse, France

Leiden University Medical Center (LUMC)

Leiden, Netherlands

Time frame: 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.

Time frame: 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.

Time frame: 36- and 60-months

Stent fracture rate

Stent fracture rate assessed at up to 30 days post-procedure, 12-, 36- and 60-months.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 30 days post-procedure, 12-, 36- and 60-months

Vessel perforation/dissection

Vessel perforation/dissection during the procedure.

Time frame: 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.

Time frame: 36- and 60-months

All cause of mortality

All cause of mortality through life of the study.

Time frame: procedure through study completion (12 months)