AndraValvulotome Post-Market Study

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.

Study Overview

• Status: Suspended
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Procedure: Valvulotomy

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Augsburg, Germany
    • University Clinic Augsburg
  • Berlin, Germany, 14129
    • Evangelisches Krankenhaus Hubertus
  • Hildesheim, Germany
    • St. Bernward Krankenhaus
  • Leipzig, Germany
    • University Clinic Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients treated with AndraValvulotome	Procedure: Valvulotomy; Valvulotomy of the venous valves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absence of device related serious adverse events (SAE)	until 30 +/- 7 days follow-up visit
Rate of not sufficiently incised venous valves	Until approximately 10 days after procedure or discharge
Pulsatile blood flow	during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Quantity of device related AE and SAE		until 30 +/- 7 days follow-up visit
Severity of device related AE and SAE		until 30 +/- 7 days follow-up visit
Quantity of passages of valvulotomy		during procedure
Primary patency rate		until 30 +/- 7 days follow-up visit
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

Collaborators and Investigators

• Sponsor: Andramed GmbH
• Investigators: Principal Investigator: Alexander Hyhlik-Dürr, MD, University Clinic Augsburg

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2021
• Primary Completion (Actual): May 30, 2022
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: VSP-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No