Post-Market Clinical Follow-up (PMCF) Study to Evaluate Safety and Performance of the DUO Venous Stent

NCT05355688 | Unknown

• 1 other identifier: ASL202101
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study is to evaluate performance and safety of the DUO Venous Stent for the treatment of obstructions of the iliac vein.

Conditions

Deep Venous Obstructions

Keywords

Venous stent system

Outcome Measures

Primary Outcomes (1)

• Primary patency rate at month 12

  The primary patency rate is defined as the percentage of stented target lesions with primary treatment success and without the occurrence of thrombosis of the treated lesion or any re-intervention (surgical interventions on the target vessel) to restore or maintain flow within the treated lesion

  12 months

Secondary Outcomes (7)

• Primary patency rates

  30 Days, 6 and 24 months

• Secondary patency rates

  30 Days, 6, 12 and 24 months

• Revised Venous Clinical Severity Score (VCSS)

  30 Days 6, 12 and 24 month

• Clinical Etiological Anatomical Pathophysiological Classification score (CEAP)

  30 Days, 6, 12 and 24 months

• Villalta score

  30 Days, 6, 12 and 24 month

Eligibility Criteria

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

Study Population

Subjects with symptomatic obstruction of the iliac vein

You may qualify if:

• Patient is willing and able to provide inform consent
• Patients must be ≥ 18 years of age at the time of consent
• Estimated life expectancy ≥ 12 months.
• Body mass index (BMI) \<35
• Patients to whom the DUO Venous Stent can be implanted according to the IFU (this includes acute iliac deep vein thrombosis (DVT), post-thrombotic syndrome, non-thrombotic iliac vein compression (e.g. May-Thurner), non-thrombotic iliac vein compression (e.g. compression from ecstatic or tortuous iliac arteries))
• As per IFU, clinically significant symptomatic venous outflow obstruction in the iliac venous segment, associated by at least one of the following:
• CEAP score ≥3
• VCSS pain score ≥2
• Subject is willing and able to comply with physician's recommendation for compression therapy -

You may not qualify if:

• Presence or history of clinically significant pulmonary emboli within 180 days prior to enrolment.
• Uncontrolled or active coagulopathy or known, incorrectable bleeding diathesis
• Prior surgical or endovascular procedure of the target vessel except for catheter-directed or mechanical thrombolysis for DVT within 90 days prior to the index procedure or prior venoplasty
• Planned surgical or interventional procedures of the target limb (except thrombolysis and/or thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in patients at high risk for pulmonary embolism) within 30 days prior to or 30 days after the index procedure
• Previous stenting of the target vessel
• Combination of stents from different manufacturers
• Participation in another investigational study in which the subject has not completed all primary endpoints or which involves any investigational drug or device that may potentially confound the results of the study
• Other comorbidities that, in the opinion of the investigator, would preclude the patient from receiving this treatment and/or participating in study-required follow-up assessments
• Women who are pregnant or lactating
• Suspected alcohol or drug abuse
• Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the study device.

Sponsors & Collaborators

• Klinikum Arnsberg: lead

Study Sites (1)

Vascular center of Klinikum Hochsauerland GmbH

Arnsberg, 59759, Germany

RECRUITING

Central Study Contacts

Michael Lichtenberg, MD

CONTACT

+49 02923 952 242; M.Lichtenberg@klinikum-hochsauerland.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 2, 2022
• Study Start: April 6, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2024
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)