PMCF Study for Peripheral Arteries Above the Knee (ATK)

Completed

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

• Registration Number: NCT05312580
• Lead Sponsor: Cordis Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-03-28
• Study First Posted: 2022-04-05
• Study Start: 2022-06-01
• Primary Completion: 2022-10-07
• Study Completion: 2022-11-07
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 387

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
All cause of mortality	procedure through study completion (12 months)	All cause of mortality through life of the study.
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.
Vessel perforation/dissection	During the procedure	Vessel perforation/dissection during the procedure.
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.
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.
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.
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.
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.

Trial Locations

Locations (9)

KABEG-Klinikum Klagenfurt am Wörthersee; 🇦🇹 Klagenfurt am Wörthersee, Austria

Public health establishment, Arras Hospital; 🇫🇷 Arras, France

Universitätsklinikum St. Pölten - Lilienfeld; 🇦🇹 St.Pölten, Austria

Leiden University Medical Center (LUMC); 🇳🇱 Leiden, Netherlands

Medizinische Universität WienMedizinische Universität Wien; 🇦🇹 Wien, Austria

Clinique River Gauche; 🇫🇷 Toulouse, France

The Public Hospital, Centre Hospitalier Universitaire de Toulouse; 🇫🇷 Toulouse, France

Hospital de la Timone; 🇫🇷 Marseille, France

Medizinische Universität Innsbruck; 🇦🇹 Innsbruck, Austria