AndraValvulotome Post-Market Study

NCT04815473 | Suspended

• 1 other identifier: VSP-001
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 4

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Quantity of device related bleeding

  until 30 +/- 7 days follow-up visit

• Severity of device related bleeding

  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

Study Arms (1)

Patients treated with AndraValvulotome

OTHER

Procedure: Valvulotomy

Interventions

Valvulotomy PROCEDURE

Valvulotomy of the venous valves

Patients treated with AndraValvulotome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andramed GmbH: lead

Study Sites (4)

University Clinic Augsburg

Augsburg, Germany

Location

Evangelisches Krankenhaus Hubertus

Berlin, 14129, Germany

Location

St. Bernward Krankenhaus

Hildesheim, Germany

Location

University Clinic Leipzig

Leipzig, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Alexander Hyhlik-Dürr, MD

  University Clinic Augsburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 25, 2021
• Study Start: April 28, 2021
• Primary Completion: May 30, 2022
• Study Completion: December 1, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

DE (4)