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Safety Profile of PETALO CVS in the Treatment of Non-thrombotic Internal Jugular Vein Stenosis and Chronic Headache

NCT04352218 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-06-02

No results posted yet for this study

Summary

The purpose of the study is to assess, as first stage, the safety profile of an innovative venous- oriented device (Petalo CVS) in the treatment of patients with non-thrombotic internal jugular vein stenosis and chronic headache resistant to best medical therapy.

After Stage 1, a second stage will be conducted to evaluate the preliminary efficacy.

Conditions

Interventions

DEVICE

PTA + Stenting using "Petalo stent"

PTA and Petalo's Stenting are a minimally invasive endovascular procedures, performed by a percutaneous access to the common femoral vein under local anesthesia and Duplex Ultrasound Guidance.

PROCEDURE

Percutaneous Transluminal Angioplasty (PTA)

PTA is a minimally invasive endovascular procedure, performed by a percutaneous access to the common femoral vein under local anesthesia and Duplex Ultrasound Guidance.

Sponsors & Collaborators

  • University of Catania

    lead OTHER

Principal Investigators

  • Veroux Pierfrancesco, MD · University of Catania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2021-04-30
Completion
2022-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04352218 on ClinicalTrials.gov