PMCF Study for Peripheral Arteries Above the Knee (ATK)

NCT05312580 | Completed

• 1 other identifier: FCRE-220105_ATK
• Study Type: observational
• Target: 387
• Locations: 3 countries
• Sites: 9

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.

Conditions

Peripheral Arterial Disease; Femoropopliteal Stenosis; Angiopathy, Peripheral

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

• Technical success rate

  During the procedure

• Technical success rate

  Day of procedure

• Freedom from CD-TLR

  36- and 60-months

• Stent fracture rate

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cordis US Corp.: lead
• FCRE (Foundation for Cardiovascular Research and Education): collaborator

Study Sites (9)

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

KABEG-Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

Location

Universitätsklinikum St. Pölten - Lilienfeld

Sankt Pölten, 3100, Austria

Location

Medizinische Universität WienMedizinische Universität Wien

Vienna, 1090, Austria

Location

Public health establishment, Arras Hospital

Arras, 31059, France

Location

Hospital de la Timone

Marseille, 13354, France

Location

The Public Hospital, Centre Hospitalier Universitaire de Toulouse

Toulouse, 31059, France

Location

Clinique River Gauche

Toulouse, 31300, France

Location

Leiden University Medical Center (LUMC)

Leiden, 2333, Netherlands

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 5, 2022
• Study Start: June 1, 2022
• Primary Completion: October 7, 2022
• Study Completion: November 7, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); AU (4); NL (1)