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

NCT ID: NCT05355688

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-06
• Study Completion Date: 2024-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Patient is willing and able to provide inform consent

2. Patients must be ≥ 18 years of age at the time of consent

3. Estimated life expectancy ≥ 12 months.

4. Body mass index (BMI) <35

5. 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))

6. 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

7. Subject is willing and able to comply with physician's recommendation for compression therapy -

Exclusion Criteria

1. Presence or history of clinically significant pulmonary emboli within 180 days prior to enrolment.

2. Uncontrolled or active coagulopathy or known, incorrectable bleeding diathesis

3. 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

4. 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

5. Previous stenting of the target vessel

6. Combination of stents from different manufacturers

7. 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

8. 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

9. Women who are pregnant or lactating

10. Suspected alcohol or drug abuse

11. Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the study device.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Klinikum Arnsberg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vascular center of Klinikum Hochsauerland GmbH

Arnsberg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Michael Lichtenberg, MD

Role: CONTACT

M.Lichtenberg@klinikum-hochsauerland.de

+49 02923 952 242 ext. 201

Facility Contacts

study office of Vascular Center

Role: primary

studienzentrum-angiologie@klinikum-hochsauerland.de

Other Identifiers

ASL202101

Identifier Type: -

Identifier Source: org_study_id