AndraValvulotome Post-Market Study

Study Overview
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Brief Summary
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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.

Official Title
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AndraValvulotome Post-Market Study

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Procedure: Valvulotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients treated with AndraValvulotome<br> | Procedure: Valvulotomy<br>* Valvulotomy of the venous valves<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |