Deep Venous ObstructionsNCT05355688
Post-Market Clinical Follow-up (PMCF) Study to Evaluate Safety and Performance of the DUO Venous Stent
An observational study of Deep Venous Obstructions, run by Klinikum Arnsberg at 1 site in Germany.
Trial summary
This observational study is to evaluate performance and safety of the DUO Venous Stent for the treatment of obstructions of the iliac vein. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Venous Obstructions
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 6 Apr 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with symptomatic obstruction of the iliac vein
Who may be able to join
- 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:
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- CEAP score ≥3
- VCSS pain score ≥2
- Subject is willing and able to comply with physician's recommendation for compression therapy -
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Vascular center of Klinikum Hochsauerland GmbH
Arnsberg, 59759
study office of Vascular Center, studienzentrum-angiologie@klinikum-hochsauerland.de
About this study
Official title: 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.
- Conditions
- Deep Venous Obstructions
- Keywords
- Venous stent system
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (7)
Primary patency rates
Measured: 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
Measured: 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).
Measured: 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
Measured: 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).
Measured: 30 Days, 6, 12 and 24 month
Device or procedure-related adverse events
Measured: 30 Days, 6, 12 and 24 month
Serious adverse events
Measured: 30 Days, 6, 12 and 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start6 Apr 2022
- Primary completionAug 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous ObstructionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum Arnsberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355688
- Sponsor's protocol ID
- ASL202101
- Status last verified
- May 2022
- First submitted
- 26 Apr 2022
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-centre Post-Market Clinical Follow-up (PMCF) Study to Evaluate Safety and Performance of the DUO Venous Stent
- ClinicalTrials.gov ID
- NCT05355688
- Acronym / sponsor ID
- ASL202101
- Conditions
- Deep Venous Obstructions
- Keywords
- Venous stent system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Klinikum ArnsbergUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study is to evaluate performance and safety of the DUO Venous Stent for the treatment of obstructions of the iliac vein.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with symptomatic obstruction of the iliac vein
Key inclusion criteria (9 listed)
- 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))
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary patency rate at month 12
Time frame: 12 months
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
7 secondary outcomes
Primary patency rates
Time frame: 30 Days, 6 and 24 months
Secondary patency rates
Time frame: 30 Days, 6, 12 and 24 months
Revised Venous Clinical Severity Score (VCSS)
Time frame: 30 Days 6, 12 and 24 month
Clinical Etiological Anatomical Pathophysiological Classification score (CEAP)
Time frame: 30 Days, 6, 12 and 24 months
Villalta score
Time frame: 30 Days, 6, 12 and 24 month
Device or procedure-related adverse events
Time frame: 30 Days, 6, 12 and 24 month
Serious adverse events
Time frame: 30 Days, 6, 12 and 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No
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Vflower Stent System for Iliofemoral Vein Stenosis and Occlusion: A Multicenter Real-World Study
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The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study
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The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Venous Obstructions, run by Klinikum Arnsberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Lichtenberg, MD (+49 02923 952 242 ext. 201, M.Lichtenberg@klinikum-hochsauerland.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency rate at month 12 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.