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

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

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

Study Overview

• Status: Recruiting
• Conditions: Deep Venous Obstructions

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Michael Lichtenberg, MD; Phone Number: 201 +49 02923 952 242; Email: M.Lichtenberg@klinikum-hochsauerland.de

Study Locations

• Germany
  • Arnsberg, Germany, 59759
    • Recruiting
    • Vascular center of Klinikum Hochsauerland GmbH
    • Contact: study office of Vascular Center; Email: studienzentrum-angiologie@klinikum-hochsauerland.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects with symptomatic obstruction of the iliac vein

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency rates		30 Days, 6 and 24 months
Secondary patency rates	Percentage of patients with primary treatment success and without occurrence of permanent loss of flow in the treated segment, irrespective of any reintervention	30 Days, 6, 12 and 24 months
Revised Venous Clinical Severity Score (VCSS)	The score includes 10 clinical parameters (pain, varicose veins, venous edema, skin hyperpigmentation, inflammation, induration, number of ulcers, durations of ulcers, size of ulcers, and compliance with compression therapy). Each item is graded from zero to three depending on severity (None = 0, Mild = 1, Moderate = 2, Severe = 3).	30 Days 6, 12 and 24 month
Clinical Etiological Anatomical Pathophysiological Classification score (CEAP)	The score for the clinical condition of the chronic venous insufficiency (C0 to C6) will be evaluated whereas C0 is representing the best and C6 the worst condition	30 Days, 6, 12 and 24 months
Villalta score	The score includes five symptoms (pain, cramps, heaviness, paresthesia, pruritus) and six clinical signs (pretibial edema, skin induration, hyperpigmentation, redness, venous ectasia, pain on calf compression).Each item is graded from zero (not present)to three (severe).	30 Days, 6, 12 and 24 month
Device or procedure-related adverse events		30 Days, 6, 12 and 24 month
Serious adverse events		30 Days, 6, 12 and 24 month

Collaborators and Investigators

• Sponsor: Klinikum Arnsberg

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Venous stent system
• Other Study ID Numbers: ASL202101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No