PMCF Study for Peripheral Arteries Below the Knee (BTK)

NCT05444660 | Completed

• 1 other identifier: FCRE 220104
• Study Type: observational
• Target: 102
• Locations: 2 countries
• Sites: 5

Brief Summary

The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-word population of 100 patients who underwent an endovascular intervention within standard-of-care (SOC) of the infra-popliteal vessels, using at least one of the products (named above) from Cordis US Corp.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (4)

• Number of Patients without Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs

  Primary Safety Endpoint Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs)

  30 days post procedure

• Number of Patients without Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs

  Primary Safety Endpoint Freedom from device and procedure related death.

  30 days post procedure

• Technical success rate

  Technical success rate defined as successful crossing, introduction, deflation and a \<30% residual stenosis on visual assessment of the SABER OTW PTA Catheter, SABERX PTA Catheter, and/or the Powerflex Pro PTA Catheter according to the respective IFU.

  during surgery

• Number of Participants without Freedom from clinically-driven target lesion revascularization (CD-TLR)

  Primary Efficacy Endpoint The primary efficacy endpoint is freedom from clinically-driven target lesion revascularization (CD-TLR)

  30 days post procedure

Secondary Outcomes (11)

• Technical success rate

  during surgery

• Technical success rate

  during surgery up to 24 hours after surgery

• Number of Participants without Freedom from clinically-driven target lesion revascularization (CD-TLR)

  30 days post-procedure

• Change of ABI Index

  30 days post-procedure

• Time-to-hemostasis (HTC)

  up to 24 hours after surgery

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

Diseased patients with PAD who underwent an endovascular intervention within standard-of-care (SOC) of the infra-popliteal vessels. In this PMCF study, data from minimally invasive medical devices will be collected. Indications for which the study devices are intended are listed in section 3.1. Patient's data will be selected based on the investigator's assessment and evaluation of the underlying disease. The patient's medical condition should have been stable, with no underlying medical condition which would prevent them from undergoing the required endovascular intervention at the time of procedure. The total sample size for this PMCF study is 100 patients, divided over up to 10 sites, throughout an enrolment period of 6 months.

You may qualify if:

• Patient is \>18 years old.
• Target Lesion is located in the infrapopliteal arteries.
• Patient who underwent treatment (PTA) in the infrapopliteal vessels with at least one of the SABER OTW PTA Catheter the SABERX PTA Catheter and/or the Powerflex Pro PTA Catheter as described in the IFU for each device.

You may not qualify if:

• Anatomy or size of vessels that would have not allowed appropriate usage of the study devices, following IFU of the study devices.
• Patients who were not suitable for receiving interventional surgeries of lower limb arteries for treatment.
• Women who were pregnant or lactating at time of the procedure.
• Any patient who was considered to be hemodynamically unstable at onset of procedure.
• Patient was not available for follow up at the clinical site.

Sponsors & Collaborators

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

Study Sites (5)

Tirol Kliniken GmbH

Innsbruck, Austria

Location

Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

Location

Medizinische Universität

Vienna, Austria

Location

Krankenhäuser Landkreis Freudenstadt gGmbH

Freudenstadt, 72250, Germany

Location

SRH Klinikum Karlsbad-Langensteinbach GmbH

Langensteinbach, 76307, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: July 6, 2022
• Study Start: May 5, 2022
• Primary Completion: September 9, 2022
• Study Completion: November 2, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); DE (2)