AndraValvulotome Post-Market Study

Peripheral Arterial Disease Clinical Trial

Official title:

AndraValvulotome Post-Market Study

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04815473
• Other study ID #: VSP-001
• Status: Suspended
• Phase: N/A
• Start date: April 28, 2021
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: Andramed GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 59
• Est. completion date: December 2023
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Procedure:
• Valvulotomy
Valvulotomy of the venous valves

Locations

Country	Name	City	State
Germany	University Clinic Augsburg	Augsburg
Germany	Evangelisches Krankenhaus Hubertus	Berlin
Germany	St. Bernward Krankenhaus	Hildesheim
Germany	University Clinic Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Andramed GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of device related serious adverse events (SAE)		until 30 +/- 7 days follow-up visit
Primary	Rate of not sufficiently incised venous valves		Until approximately 10 days after procedure or discharge
Primary	Pulsatile blood flow		during procedure
Secondary	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.	until 30 +/- 7 days follow-up visit
Secondary	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.	until 30 +/- 7 days follow-up visit
Secondary	Quantity of device related AE and SAE		until 30 +/- 7 days follow-up visit
Secondary	Severity of device related AE and SAE		until 30 +/- 7 days follow-up visit
Secondary	Quantity of passages of valvulotomy		during procedure
Secondary	Primary patency rate		until 30 +/- 7 days follow-up visit
Secondary	Primary technical success	technical success is defined as clinical efficacy after valvulotomy without the presence of device related AE and SAE	Until approximately 10 days after procedure or discharge