Clinical trial NCT05355688: Post-Market Clinical Follow-up (PMCF) Study to Evaluate Safety and Performance of the DUO Venous Stent
Official title: Prospective, Single-centre Post-Market Clinical Follow-up (PMCF) Study to Evaluate Safety and Performance of the DUO Venous Stent
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Deep Venous Obstructions
Keywords: Venous stent system
Lead sponsor: Klinikum Arnsberg
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with symptomatic obstruction of the iliac vein

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.


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.

Primary outcomes:
measure: Primary patency rate at month 12
timeFrame: 12 months
Secondary outcomes:
measure: Primary patency rates
timeFrame: 30 Days, 6 and 24 months
measure: Secondary patency rates
timeFrame: 30 Days, 6, 12 and 24 months
measure: Revised Venous Clinical Severity Score (VCSS)
timeFrame: 30 Days 6, 12 and 24 month
measure: Clinical Etiological Anatomical Pathophysiological Classification score (CEAP)
timeFrame: 30 Days, 6, 12 and 24 months
measure: Villalta score
timeFrame: 30 Days, 6, 12 and 24 month
measure: Device or procedure-related adverse events
timeFrame: 30 Days, 6, 12 and 24 month
measure: Serious adverse events
timeFrame: 30 Days, 6, 12 and 24 month
Other outcomes:
Locations:
city: Arnsberg
country: Germany
facility: Vascular center of Klinikum Hochsauerland GmbH
Study officials:
References: