Femoral Artery StenosisRESTUGPANCT05117515
Retrospective Study of the Uni-Graft® K DV Patch in the Clinical Routine
An observational study of Femoral Artery Stenosis and Iliac Artery Stenosis, run by Aesculap AG at 1 site in Germany.
Trial summary
Uni-Graft® K DV Patch is marketed in Europe since 1999 for reconstructive interventions of the deep femoral, femoral and iliac artery and was also indicated for carotid interventions until 01/2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Artery Stenosis, Iliac Artery Stenosis, Carotid Artery Stenosis
- What is being tested?
- Vascular reconstruction
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 27 Apr 2022to 27 Nov 2025
- 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: Only patients with an age ≥ 18 years at intervention, who had provided written informed consent and had been treated with Uni-Graft® K DV Patch will be eligible for documentation in this NIS. Patients who had received Uni-Graft® K DV Patch not for reconstructive interventions of the carotid, deep femoral, femoral and iliac artery will be not included in the study.
Who may be able to join
- age ≥ 18 years
- written informed consent
- treated with Uni-Graft® K DV Patch for reconstructive interventions of the carotid, deep femoral, femoral and iliac artery
Who cannot join
- Use of the Uni-Graft® K DV Patch if allergies to components of the patch are known
- Use of the Uni-Graft® K DV Patch in case of a known hypersensitive reaction to the patch and / or its components (e.g. polyethylene terephthalate).
- No use of Uni-Graft® K DV Patch
- Use of Uni-Graft® K DV Patch outside the intended use of the product at the date of application
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Retrospective Monocentric, Observational PMCF - Study on the Performance and Safety of Uni-Graft® K DV Patch in Patients With Vascular Reconstructions
Uni-Graft® K DV Patch is marketed in Europe since 1999 for reconstructive interventions of the deep femoral, femoral and iliac artery and was also indicated for carotid interventions until 01/2020. Previous studies focused on the clinical performance of different patch materials used for patch angioplasty in different indications, without specifying the product or manufacturer. Thus, it is not surprising that there is a limited amount of published literature available describing the use of the Uni-Graft® K DV Patch in the clinical routine. Therefore, the aim of the present non-interventional study (NIS) is to close this gap by collecting and evaluating existing safety and performance data documented in the clinical routine especially during the application of the Uni-Graft® K DV Patch.
- Being tested
- Vascular reconstruction
- Keywords
- Reconstructive interventions, vascular patch, polyethylene terephthalate
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular reconstructionDevice
Vascular reconstructions in the carotid, profunda, femoral and iliac arteries
| Study group | Role | What they receive |
|---|---|---|
| Uni-Graft KDV Patch | Not described Receives: Device: Vascular reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restenosis Rate in postoperative Course
Retrospective evaluation of restenosis rate from information documented in the patient file: the NASCET is an angiographic measurement recommended by the "North American Symptomatic Carotid Endarterectomy Trial"-Group. According to the NASCET-Method the grade of stenosis in relation to the diameter of the ACI distal to the stenosis in the area of the parallel arterial wall is measured.
Measured: approximately up to 3 months after Implantation
Secondary outcomes (8)
Postoperative bleeding
Retrospective evaluation of restenosis rate from information documented in the patient file: Report of any bleeding during postoperative course
Measured: approximately up to 3 months after Implantation
Rate of Intraoperative stroke
Retrospective evaluation of stroke rate from information documented in the patient file: Report of any intraoperative stroke
Measured: intraoperatively
Rate of postoperative stroke
Retrospective evaluation of stroke rate from information documented in the patient file: Report of any stroke during postoperative course
Measured: approximately up to 3 months after Implantation
Rate of patch related infections
Retrospective evaluation of any patch related infections from information documented in the patient file: Report of any patch related infections during postoperative course
Measured: approximately up to 3 months after Implantation
Rate of postoperative nerve lesions
Retrospective evaluation of nerve lesion rate from information documented in the patient file: Report of any postoperative nerve lesions postoperative course
Measured: approximately up to 3 months after Implantation
Rate of postoperative pseudoaneurysm
Retrospective evaluation of pseudoaneurysm rate from information documented in the patient file: Report of any postoperative pseudoaneurysm during postoperative course
Measured: approximately up to 3 months after Implantation
Primary and secondary patency rate
Retrospective evaluation of primary and secondary patency rate from information documented in the patient file during postoperative course
Measured: approximately up to 3 months after Implantation
Freedom of re-intervention rate
Retrospective evaluation of re-intervention rate from information documented in the patient file: Report of any re-intervention during postoperative course
Measured: approximately up to 3 months after Implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start27 Apr 2022
- Primary completion27 Nov 2024
- Study completion27 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Artery StenosisStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117515
- Sponsor's protocol ID
- AAG-O-H-2116
- Acronym
- RESTUGPA
- Status last verified
- Dec 2025
- First submitted
- 2 Nov 2021
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Monocentric, Observational PMCF - Study on the Performance and Safety of Uni-Graft® K DV Patch in Patients With Vascular Reconstructions
- ClinicalTrials.gov ID
- NCT05117515
- Acronym / sponsor ID
- RESTUGPA / AAG-O-H-2116
- Keywords
- Reconstructive interventions, vascular patch, polyethylene terephthalate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2025 (actual)
- First posted
- 11 Nov 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.
Uni-Graft® K DV Patch is marketed in Europe since 1999 for reconstructive interventions of the deep femoral, femoral and iliac artery and was also indicated for carotid interventions until 01/2020. Previous studies focused on the clinical performance of different patch materials used for patch angioplasty in different indications, without specifying the product or manufacturer. Thus, it is not surprising that there is a limited amount of published literature available describing the use of the Uni-Graft® K DV Patch in the clinical routine. Therefore, the aim of the present non-interventional study (NIS) is to close this gap by collecting and evaluating existing safety and performance data documented in the clinical routine especially during the application of the Uni-Graft® K DV Patch.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uni-Graft KDV Patch | – | Device: Vascular reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Only patients with an age ≥ 18 years at intervention, who had provided written informed consent and had been treated with Uni-Graft® K DV Patch will be eligible for documentation in this NIS. Patients who had received Uni-Graft® K DV Patch not for reconstructive interventions of the carotid, deep femoral, femoral and iliac artery will be not included in the study.
Key inclusion criteria (3 listed)
- age ≥ 18 years
- written informed consent
- treated with Uni-Graft® K DV Patch for reconstructive interventions of the carotid, deep femoral, femoral and iliac artery
Key exclusion criteria (4 listed)
- Use of the Uni-Graft® K DV Patch if allergies to components of the patch are known
- Use of the Uni-Graft® K DV Patch in case of a known hypersensitive reaction to the patch and / or its components (e.g. polyethylene terephthalate).
- No use of Uni-Graft® K DV Patch
- Use of Uni-Graft® K DV Patch outside the intended use of the product at the date of application
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 |
|---|---|---|
| Vascular reconstructionVascular reconstructions in the carotid, profunda, femoral and iliac arteries | Device | Uni-Graft KDV Patch |
Primary outcome
Restenosis Rate in postoperative Course
Time frame: approximately up to 3 months after Implantation
Retrospective evaluation of restenosis rate from information documented in the patient file: the NASCET is an angiographic measurement recommended by the "North American Symptomatic Carotid Endarterectomy Trial"-Group. According to the NASCET-Method the grade of stenosis in relation to the diameter of the ACI distal to the stenosis in the area of the parallel arterial wall is measured.
8 secondary outcomes
Postoperative bleeding
Time frame: approximately up to 3 months after Implantation
Rate of Intraoperative stroke
Time frame: intraoperatively
Rate of postoperative stroke
Time frame: approximately up to 3 months after Implantation
Rate of patch related infections
Time frame: approximately up to 3 months after Implantation
Rate of postoperative nerve lesions
Time frame: approximately up to 3 months after Implantation
Rate of postoperative pseudoaneurysm
Time frame: approximately up to 3 months after Implantation
Primary and secondary patency rate
Time frame: approximately up to 3 months after Implantation
Freedom of re-intervention rate
Time frame: approximately up to 3 months after Implantation
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 16 Dec 2025.
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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.
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 Femoral Artery Stenosis and Iliac Artery Stenosis, run by Aesculap AG 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 3 inclusion and 4 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 16 Dec 2025. 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?
Restenosis Rate in postoperative Course (time frame: approximately up to 3 months after Implantation). 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 16 Dec 2025.