Peripheral Arterial DiseaseNCT04815473
AndraValvulotome Post-Market Study
A study testing Valvulotomy in people with Peripheral Arterial Disease, run by Andramed GmbH at 4 sites in Germany.
Trial summary
The AndraValvulotome Post-Market Study is a prospective, open-label, multi-center study to evaluate the efficacy and safety of the AndraValvulotome. A maximum of 70 patients will be enrolled with peripheral artery disease (PAD) in up to 10 sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Valvulotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 4 sitesGermany
- Study dates
- 28 Apr 2021to Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- Patients with peripheral arterial disease who are planned to undergo a bypass surgery with autologous vena saphena magna and using a valvulotome.
- Patient has to be consented and a informed consent form needs to be signed.
- Patient is able to and willing to participate in the 30 days follow-up.
- Vein diameter is at least 2mm (4F system) and 3mm (5F system).
- Vein diameter does not exceed 8mm (OTW-version) or 6mm (TIP-version)
- Bypass needs to be a continuous vena saphena magna with a length of at least 20cm.
- Rutherford category III - VI
Who cannot join
- Patients who have not completed 18 years of age
- Patients who are pregnant or assuming to be pregnant, and breast feeding.
- Patients who cannot participate due to medical or physical condition based on the decision of the physician.
- Life expectancy less than 1 year
- Known allergies to materials of the tip, cutting basket, outer catheter, kink protection and braid.
- Rutherford category 0-2
- Using varicose vein
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
University Clinic Augsburg
Augsburg
Evangelisches Krankenhaus Hubertus
Berlin, 14129
St. Bernward Krankenhaus
Hildesheim
University Clinic Leipzig
Leipzig
About this study
The AndraValvulotome Post-Market Study is a prospective, open-label, multi-center study to evaluate the efficacy and safety of the AndraValvulotome. A maximum of 70 patients will be enrolled with peripheral artery disease (PAD) in up to 10 sites. Study participants will be primarily observed during the bypass procedure. In addition, the patients will be re-evaluated at the follow-up visit which will be scheduled 30 +/- 7 days after beginning of the study participation.
The objective of this study is to analyze the efficacy and safety of the valvulotomy of the venous valves with the CE marked AndraValvulotome during the bypass procedure.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Valvulotomy
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValvulotomyProcedure or surgery
Valvulotomy of the venous valves
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with AndraValvulotome | Other | Not described Receives: Procedure: Valvulotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of device related serious adverse events (SAE)
Measured: until 30 +/- 7 days follow-up visit
Rate of not sufficiently incised venous valves
Measured: Until approximately 10 days after procedure or discharge
Pulsatile blood flow
Measured: during procedure
Secondary outcomes (7)
Quantity of device related bleeding
A device related bleeding could occur due to the application of the device. Bleeding is defined as a decrease of a value of 2 hemoglobin points.
Measured: until 30 +/- 7 days follow-up visit
Severity of device related bleeding
A device related bleeding could occur due to the application of the device. Bleeding is defined as a decrease of a value of 2 hemoglobin points.
Measured: until 30 +/- 7 days follow-up visit
Quantity of device related AE and SAE
Measured: until 30 +/- 7 days follow-up visit
Severity of device related AE and SAE
Measured: until 30 +/- 7 days follow-up visit
Quantity of passages of valvulotomy
Measured: during procedure
Primary patency rate
Measured: until 30 +/- 7 days follow-up visit
Primary technical success
technical success is defined as clinical efficacy after valvulotomy without the presence of device related AE and SAE
Measured: Until approximately 10 days after procedure or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start28 Apr 2021
- Primary completion30 May 2022
- Study completionDec 2023 (estimated)
Why it stopped: The number of evaluated valves were achieved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andramed GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Hyhlik-Dürr, MD, Principal investigator, University Clinic Augsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815473
- Sponsor's protocol ID
- VSP-001
- Status last verified
- Oct 2023
- First submitted
- 19 Mar 2021
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AndraValvulotome Post-Market Study
- ClinicalTrials.gov ID
- NCT04815473
- Acronym / sponsor ID
- VSP-001
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The number of evaluated valves were achieved.
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Andramed GmbHIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 Mar 2021 (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 AndraValvulotome Post-Market Study is a prospective, open-label, multi-center study to evaluate the efficacy and safety of the AndraValvulotome. A maximum of 70 patients will be enrolled with peripheral artery disease (PAD) in up to 10 sites. Study participants will be primarily observed during the bypass procedure. In addition, the patients will be re-evaluated at the follow-up visit which will be scheduled 30 +/- 7 days after beginning of the study participation.
The objective of this study is to analyze the efficacy and safety of the valvulotomy of the venous valves with the CE marked AndraValvulotome during the bypass procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with AndraValvulotome | Other | Procedure: Valvulotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with peripheral arterial disease who are planned to undergo a bypass surgery with autologous vena saphena magna and using a valvulotome.
- Patient has to be consented and a informed consent form needs to be signed.
- Patient is able to and willing to participate in the 30 days follow-up.
- Vein diameter is at least 2mm (4F system) and 3mm (5F system).
- Vein diameter does not exceed 8mm (OTW-version) or 6mm (TIP-version)
Key exclusion criteria (7 listed)
- Patients who have not completed 18 years of age
- Patients who are pregnant or assuming to be pregnant, and breast feeding.
- Patients who cannot participate due to medical or physical condition based on the decision of the physician.
- Life expectancy less than 1 year
- Known allergies to materials of the tip, cutting basket, outer catheter, kink protection and braid.
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 |
|---|---|---|
| ValvulotomyValvulotomy of the venous valves | Procedure or surgery | Patients treated with AndraValvulotome |
Primary outcome
Absence of device related serious adverse events (SAE)
Time frame: until 30 +/- 7 days follow-up visit
Rate of not sufficiently incised venous valves
Time frame: Until approximately 10 days after procedure or discharge
Pulsatile blood flow
Time frame: during procedure
7 secondary outcomes
Quantity of device related bleeding
Time frame: until 30 +/- 7 days follow-up visit
Severity of device related bleeding
Time frame: until 30 +/- 7 days follow-up visit
Quantity of device related AE and SAE
Time frame: until 30 +/- 7 days follow-up visit
Severity of device related AE and SAE
Time frame: until 30 +/- 7 days follow-up visit
Quantity of passages of valvulotomy
Time frame: during procedure
Primary patency rate
Time frame: until 30 +/- 7 days follow-up visit
Primary technical success
Time frame: Until approximately 10 days after procedure or discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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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.
Alexander Hyhlik-Dürr, MD principal investigator
University Clinic Augsburg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valvulotomy in people with Peripheral Arterial Disease, run by Andramed GmbH at 4 sites 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 7 inclusion and 7 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: paused, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Absence of device related serious adverse events (SAE) (time frame: until 30 +/- 7 days follow-up visit). The study lists 3 primary outcomes in all. 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 18 Oct 2023.