Clinical trial NCT04815473: AndraValvulotome Post-Market Study
Official title: AndraValvulotome Post-Market Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Andramed GmbH
Sponsor class: INDUSTRY
First posted: 2021-03-25
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Exclusion criteria based on IFU

Primary outcomes:
measure: Absence of device related serious adverse events (SAE)
timeFrame: until 30 +/- 7 days follow-up visit
measure: Rate of not sufficiently incised venous valves
timeFrame: Until approximately 10 days after procedure or discharge
measure: Pulsatile blood flow
timeFrame: during procedure
Secondary outcomes:
measure: Quantity of device related bleeding
timeFrame: until 30 +/- 7 days follow-up visit
measure: Severity of device related bleeding
timeFrame: until 30 +/- 7 days follow-up visit
measure: Quantity of device related AE and SAE
timeFrame: until 30 +/- 7 days follow-up visit
measure: Severity of device related AE and SAE
timeFrame: until 30 +/- 7 days follow-up visit
measure: Quantity of passages of valvulotomy
timeFrame: during procedure
measure: Primary patency rate
timeFrame: until 30 +/- 7 days follow-up visit
measure: Primary technical success
timeFrame: Until approximately 10 days after procedure or discharge
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: University Clinic Augsburg
city: Berlin
country: Germany
facility: Evangelisches Krankenhaus Hubertus
city: Hildesheim
country: Germany
facility: St. Bernward Krankenhaus
city: Leipzig
country: Germany
facility: University Clinic Leipzig
Study officials:
affiliation: University Clinic Augsburg
name: Alexander Hyhlik-Dürr, MD
role: PRINCIPAL_INVESTIGATOR
References: