Diseased or Occluded Blood VesselsNCT04620889
LeMaitre LifeSpan® ePTFE Vascular Graft Retrospective Registry
An observational study of Diseased or Occluded Blood Vessels and Arteriovenous Shunting for Blood Access, run by LeMaitre Vascular at 1 site in Germany.
Trial summary
This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diseased or Occluded Blood Vessels, Arteriovenous Shunting for Blood Access
- What is being tested?
- AV Access and PVP
- Type of treatment
- Medical device
- How many people
- 153 participants
- Where
- 1 siteGermany
- Study dates
- 27 Nov 2020to 24 Nov 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a retrospective registry. The included population is therefore directly representative of the population in a real-world environment.
Who may be able to join
- Subject has undergone surgical treatment with the LifeSpan.
- Surgical treatment was for bypass or reconstruction of diseased or occluded blood vessels (PVP group) or arteriovenous shunting for blood access (AV group).
- For PVP group: Subject's surgical treatment was at minimum 3 years ago, and maximum 10 years ago, at time of enrollment.
- For AV group: Subject's surgical treatment was at minimum 2 years ago, and maximum 10 years ago, at time of enrollment.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Patient Registry on the Long-Term Safety and Performance of the LifeSpan® ePTFE Vascular Graft Used in Open Vascular Surgery
This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search.
Read the detailed description
This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search. Data will be captured retrospectively. Subjects will have been treated with the investigational device in the past and according to standard of care. Subjects will not be involved in any registry related procedures.
- Being tested
- AV Access, PVP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV AccessDevice
Arteriovenous shunting for blood access.
PVPDevice
Bypass or reconstruction of diseased or occluded blood vessels
| Study group | Role | What they receive |
|---|---|---|
| PVP (peripheral vascular disease) | Bypass or reconstruction of diseased or occluded blood vessels Receives: Device: PVP | |
| AV Access (arteriovenous access) | Arteriovenous shunting for blood access and bypass. Receives: Device: AV Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of vessels patent without requiring intervention to remain open
Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up
Measured: 3 years
Percentage of vessels patent without requiring intervention to remain open
Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up
Measured: 2 years
Secondary outcomes (6)
Procedure type
Type of procedure
Measured: Day of procedure
Intra-operative technical success
Percentage of patients with proper functioning of the device in the opinion of the investigator at time of surgery
Measured: Day of procedure
Percentage of vessels patent without requiring intervention to remain open at 1 and 5 year primary patency
Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up
Measured: 1 year and 5 year
Percentage of vessels patent with intervention to remain open at 1 and 5 year
Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up after interventions
Measured: 1 year and 5 year
Percentage of vessels patent with intervention to remain open at 1 and 5 year for AV Access
Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up after interventions
Measured: 2 year
Percentage of vessels patent with intervention to remain open at 1 and 5 year for PVP Group
Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up after interventions
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start27 Nov 2020
- Primary completion24 Nov 2023
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diseased or Occluded Blood VesselsStudies 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
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- LeMaitre Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620889
- Sponsor's protocol ID
- LFP-15-001
- Status last verified
- Oct 2024
- First submitted
- 3 Nov 2020
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a fully anonymized registry. No IPD will be collected or shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Patient Registry on the Long-Term Safety and Performance of the LifeSpan® ePTFE Vascular Graft Used in Open Vascular Surgery
- ClinicalTrials.gov ID
- NCT04620889
- Acronym / sponsor ID
- LFP-15-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- LeMaitre VascularIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 9 Nov 2020 (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 is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search.
Detailed description
This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search. Data will be captured retrospectively. Subjects will have been treated with the investigational device in the past and according to standard of care. Subjects will not be involved in any registry related procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVP (peripheral vascular disease) | – | Device: PVPBypass or reconstruction of diseased or occluded blood vessels |
| AV Access (arteriovenous access) | – | Device: AV AccessArteriovenous shunting for blood access and bypass. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a retrospective registry. The included population is therefore directly representative of the population in a real-world environment.
Key inclusion criteria (4 listed)
- Subject has undergone surgical treatment with the LifeSpan.
- Surgical treatment was for bypass or reconstruction of diseased or occluded blood vessels (PVP group) or arteriovenous shunting for blood access (AV group).
- For PVP group: Subject's surgical treatment was at minimum 3 years ago, and maximum 10 years ago, at time of enrollment.
- For AV group: Subject's surgical treatment was at minimum 2 years ago, and maximum 10 years ago, at time of enrollment.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| AV AccessArteriovenous shunting for blood access. | Device | AV Access (arteriovenous access) |
| PVPBypass or reconstruction of diseased or occluded blood vessels | Device | PVP (peripheral vascular disease) |
Primary outcome
Percentage of vessels patent without requiring intervention to remain open
Time frame: 3 years
Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up
Percentage of vessels patent without requiring intervention to remain open
Time frame: 2 years
Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up
6 secondary outcomes
Procedure type
Time frame: Day of procedure
Intra-operative technical success
Time frame: Day of procedure
Percentage of vessels patent without requiring intervention to remain open at 1 and 5 year primary patency
Time frame: 1 year and 5 year
Percentage of vessels patent with intervention to remain open at 1 and 5 year
Time frame: 1 year and 5 year
Percentage of vessels patent with intervention to remain open at 1 and 5 year for AV Access
Time frame: 2 year
Percentage of vessels patent with intervention to remain open at 1 and 5 year for PVP Group
Time frame: 3 year
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 18 Oct 2024.
- Individual participant dataSharing planned: No. This is a fully anonymized registry. No IPD will be collected or shared.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diseased or Occluded Blood Vessels and Arteriovenous Shunting for Blood Access, run by LeMaitre Vascular 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 4 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 18 Oct 2024. 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?
Percentage of vessels patent without requiring intervention to remain open (time frame: 3 years). The study lists 2 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 2024.