AndraValvulotome Post-Market Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-28

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Retrospective Post-Market Clinical Follow-Up Study of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft in Peripheral Artery Disease, Aortic Aneurysms, and Dialysis Access

NCT05124184

PAD - Peripheral Arterial Disease AAA - Abdominal Aortic Aneurysm End-Stage Renal Disease

COMPLETED

Preservation of Venous Valvular Function After PMT for Acute DVT

NCT05588284

Acute Deep Venous Thrombosis of Femoral Vein (Disorder)

ENROLLING_BY_INVITATION NA

Evaluation of All'InCath in Peripheral Vasculature Percutaneous Transluminal Angioplasty.

NCT05153421

Vascular Diseases

TERMINATED NA

PMCF of Rotarex®S & Aspirex®S Catheters in Treating Thrombotic Occlusion of Arteriovenous Graft

NCT05071872

Arteriovenous Graft Thrombosis

COMPLETED

Evaluation of All'InCath in Peripheral Vasculature Percutaneous Transluminal Angioplasty.

NCT05497440

Vascular Diseases

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Arterial Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients treated with AndraValvulotome

Group Type OTHER

Valvulotomy

Intervention Type PROCEDURE

Valvulotomy of the venous valves

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Valvulotomy

Valvulotomy of the venous valves

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No