Clinical trial NCT05117515: Retrospective Study of the Uni-Graft® K DV Patch in the Clinical Routine
Official title: Retrospective Monocentric, Observational PMCF - Study on the Performance and Safety of Uni-Graft® K DV Patch in Patients With Vascular Reconstructions
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Femoral Artery Stenosis
Iliac Artery Stenosis
Carotid Artery Stenosis
Keywords: Reconstructive interventions
vascular patch
polyethylene terephthalate
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2021-11-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Restenosis Rate in postoperative Course
timeFrame: approximately up to 3 months after Implantation
Secondary outcomes:
measure: Postoperative bleeding
timeFrame: approximately up to 3 months after Implantation
measure: Rate of Intraoperative stroke
timeFrame: intraoperatively
measure: Rate of postoperative stroke
timeFrame: approximately up to 3 months after Implantation
measure: Rate of patch related infections
timeFrame: approximately up to 3 months after Implantation
measure: Rate of postoperative nerve lesions
timeFrame: approximately up to 3 months after Implantation
measure: Rate of postoperative pseudoaneurysm
timeFrame: approximately up to 3 months after Implantation
measure: Primary and secondary patency rate
timeFrame: approximately up to 3 months after Implantation
measure: Freedom of re-intervention rate
timeFrame: approximately up to 3 months after Implantation
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
state: Nordrhein-Westfalen
Study officials:
References: