Back to resultsAndraValvulotome Post-Market Study
Primary Purpose
Peripheral Arterial Disease
Status
Suspended
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Valvulotomy
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
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
Sites / Locations
- University Clinic Augsburg
- Evangelisches Krankenhaus Hubertus
- St. Bernward Krankenhaus
- University Clinic Leipzig
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients treated with AndraValvulotome
Arm Description
Outcomes
Primary Outcome Measures
Absence of device related serious adverse events (SAE)
Rate of not sufficiently incised venous valves
Pulsatile blood flow
Secondary Outcome Measures
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.
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.
Quantity of device related AE and SAE
Severity of device related AE and SAE
Quantity of passages of valvulotomy
Primary patency rate
Primary technical success
technical success is defined as clinical efficacy after valvulotomy without the presence of device related AE and SAE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04815473
Brief Title
AndraValvulotome Post-Market Study
Official Title
AndraValvulotome Post-Market Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Suspended
Why Stopped
The number of evaluated valves were achieved.
Study Start Date
April 28, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Andramed GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients treated with AndraValvulotome
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Valvulotomy
Intervention Description
Valvulotomy of the venous valves
Primary Outcome Measure Information:
Title
Absence of device related serious adverse events (SAE)
Time Frame
until 30 +/- 7 days follow-up visit
Title
Rate of not sufficiently incised venous valves
Time Frame
Until approximately 10 days after procedure or discharge
Title
Pulsatile blood flow
Time Frame
during procedure
Secondary Outcome Measure Information:
Title
Quantity of device related bleeding
Description
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.
Time Frame
until 30 +/- 7 days follow-up visit
Title
Severity of device related bleeding
Description
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.
Time Frame
until 30 +/- 7 days follow-up visit
Title
Quantity of device related AE and SAE
Time Frame
until 30 +/- 7 days follow-up visit
Title
Severity of device related AE and SAE
Time Frame
until 30 +/- 7 days follow-up visit
Title
Quantity of passages of valvulotomy
Time Frame
during procedure
Title
Primary patency rate
Time Frame
until 30 +/- 7 days follow-up visit
Title
Primary technical success
Description
technical success is defined as clinical efficacy after valvulotomy without the presence of device related AE and SAE
Time Frame
Until approximately 10 days after procedure or discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Hyhlik-Dürr, MD
Organizational Affiliation
University Clinic Augsburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic Augsburg
City
Augsburg
Country
Germany
Facility Name
Evangelisches Krankenhaus Hubertus
City
Berlin
ZIP/Postal Code
14129
Country
Germany
Facility Name
St. Bernward Krankenhaus
City
Hildesheim
Country
Germany
Facility Name
University Clinic Leipzig
City
Leipzig
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
AndraValvulotome Post-Market Study
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