Deep Vein ThrombosisNCT05740410
Retrospective Analysis for the ClotTriever Catheter to Investigate Safety and Effectiveness in the Treatment of Acute and Subacute Iliofemoral Deep Vein Thrombosis (DVT)
An observational study of Deep Vein Thrombosis, run by Klinikum Arnsberg at 1 site in Germany.
Trial summary
The aim of the study is to evaluate the safety and performance of the ClotTriever catheter in the treatment of patients with symptomatic iliofemoral deep vein thrombosis (DVT) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- ClotTriever Catheter
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 12 Apr 2021to 20 Jul 2022
- 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
- Adult, Older adult
Study population: patients treated in the vascular center of the clinic
Who may be able to join
- uni or bilateral iliofemoral DVT
Who cannot join
- previously stented in treatment vein
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the safety and performance of the ClotTriever catheter in the treatment of patients with symptomatic iliofemoral deep vein thrombosis (DVT)
Read the detailed description
Data from patients in whom the ClotTriever catheter was used for treatment of iliofemoral DVT was retrospectively collected for up to 6 months after the procedure for evaluation of safety and effectiveness.
- Conditions
- Deep Vein Thrombosis
- Being tested
- ClotTriever Catheter
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClotTriever CatheterDevice
Treatment of iliofemoral deep vein thrombosis with the ClotTriever catheter
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
Restauration of inflow in the treated vein
Measured: directly after treatment of the vein (Day 0)
Secondary outcomes (4)
Incidence of ClotTriever related major adverse events (MAE)
MAEs defined as death, major amputation or any clinically driven target lesion revascularisation
Measured: 1 month
Number of lesions with at least Society Interventional Radiology (SIR) Grad II Lyse (50-95% thrombus removal)
Society Interventional Radiology (SIR) Grad II Lyse (50-95 % thrombus removal) or greater at the end of the procedure including adjunctive treatments
Measured: directly after treatment of the vein (Day 0)
Vilallta score
Score for post thrombotic syndrome (PTS) assessing 5 subjective symptoms (pain, cramps, heaviness, paresthesia, pruritus) and 6 clinical signs (pretibial edema, skin induration, hyperpigmentation, redness, venous ectasia, pain on calf compression) with a 4-point scale from 0 (not present) to 3 (severe).
Measured: Day 0, month 1 and 6
Venous clinical severity score (VCSS)
Score of 10 parameters each assessed by severity 0-3.
Measured: Day 0, month 1 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start12 Apr 2021
- Primary completion17 Jan 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies 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
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Arnsberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael H Lichtenberg, MD, Principal investigator, Klinikum Hochsauerland GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740410
- Sponsor's protocol ID
- ClotTriever
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not planned to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis for the ClotTriever Catheter to Investigate Safety and Effectiveness in the Treatment of Acute and Subacute Iliofemoral Deep Vein Thrombosis (DVT)
- ClinicalTrials.gov ID
- NCT05740410
- Acronym / sponsor ID
- ClotTriever
- Conditions
- Deep Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Klinikum ArnsbergUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 23 Feb 2023 (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.
The aim of the study is to evaluate the safety and performance of the ClotTriever catheter in the treatment of patients with symptomatic iliofemoral deep vein thrombosis (DVT)
Detailed description
Data from patients in whom the ClotTriever catheter was used for treatment of iliofemoral DVT was retrospectively collected for up to 6 months after the procedure for evaluation of safety and effectiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients treated in the vascular center of the clinic
Key inclusion criteria (1 listed)
- uni or bilateral iliofemoral DVT
Key exclusion criteria (1 listed)
- previously stented in treatment vein
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClotTriever CatheterTreatment of iliofemoral deep vein thrombosis with the ClotTriever catheter | Device | – |
Primary outcome
Procedural success
Time frame: directly after treatment of the vein (Day 0)
Restauration of inflow in the treated vein
4 secondary outcomes
Incidence of ClotTriever related major adverse events (MAE)
Time frame: 1 month
Number of lesions with at least Society Interventional Radiology (SIR) Grad II Lyse (50-95% thrombus removal)
Time frame: directly after treatment of the vein (Day 0)
Vilallta score
Time frame: Day 0, month 1 and 6
Venous clinical severity score (VCSS)
Time frame: Day 0, month 1 and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No. It is not planned to share IPD
Related trials for Deep Vein Thrombosis
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Active, not recruiting
This Research Proposal Focuses on Evaluating the Effectiveness of a Nursing Care Protocol in Preventing Deep Vein Thrombosis (DVT) in Patients Undergoing On-pump Cardiac Surgery. The Study Will Include an Intervention Group That Receives the Nursing Protocol and a Control Group That Receives Routine
On-pump Cardiac Surgery - Prevention - Intervention - Experimental Group - Control Group - Incidence - Complications, DVT - Deep Vein Thrombosis
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
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.
Michael H Lichtenberg, MD principal investigator
Klinikum Hochsauerland GmbH
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 Vein Thrombosis, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success (time frame: directly after treatment of the vein (Day 0)). 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 23 Feb 2023.