AndraValvulotome Post-Market Study

Not Applicable

Suspended

• Conditions: Peripheral Arterial Disease
• Interventions: Procedure: Valvulotomy

• Registration Number: NCT04815473
• Lead Sponsor: Andramed GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-25
• Study Start: 2021-04-28
• Primary Completion: 2022-05-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients treated with AndraValvulotome	Valvulotomy	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Severity of device related bleeding	until 30 +/- 7 days follow-up visit	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.
Primary patency rate	until 30 +/- 7 days follow-up visit
Primary technical success	Until approximately 10 days after procedure or discharge	technical success is defined as clinical efficacy after valvulotomy without the presence of device related AE and SAE
Quantity of device related AE and SAE	until 30 +/- 7 days follow-up visit
Quantity of passages of valvulotomy	during procedure
Quantity of device related bleeding	until 30 +/- 7 days follow-up visit	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.
Severity of device related AE and SAE	until 30 +/- 7 days follow-up visit

Trial Locations

Locations (4)

Evangelisches Krankenhaus Hubertus; 🇩🇪 Berlin, Germany

University Clinic Leipzig; 🇩🇪 Leipzig, Germany

University Clinic Augsburg; 🇩🇪 Augsburg, Germany

St. Bernward Krankenhaus; 🇩🇪 Hildesheim, Germany