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

Unknown statusPhase 2NCT04352218
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Novel Compliant Scaffold With Specific Design for the Treatment of Non-thrombotic Stenosis of Internal Jugular Veins in Patients With Chronic Headache Poor Responder to Best Medical Therapy
Conditions
Interventions
  • Device: PTA + Stenting using "Petalo stent"
  • Procedure: Percutaneous Transluminal Angioplasty (PTA)
Sponsor
University of Catania
Start date
2020-09
Primary completion
2021-04
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Total sites listed
0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Male and female patients aged ≥ 18 * Patients undergoing Echo color Doppler ultrasound with unilateral or bilateral non-thrombotic stenosis \> 50% of IJV * Patients suffering from headache not responsive to two medical treatments with diagnosis of chronic migraine or chronic tension-type headache according to the criteria of the International Classification of Headache Disorders (ICHD-3 beta). * Subject able to comprehend the full nature and purpose of the study, including possible risks and side effects; able to co-operate with the Investigator and to comply with the requirements of the entire study. * Subject available for the whole study period and gave written informed consent prior to inclusion in the study Exclusion Criteria: * Patients with unilateral or bilateral thrombosis stenosis of IJV. * Patients with severe hypoplasia of IJV with diameter \< 5mm. * Presence of pacemaker. * Dural venous sinus stenosis \> 50% * Documented severe intolerance to iodinated contrast medium. * Non-compliance with pharmacological treatment * Intracranial abnormalities such as tumor, abscess and vascular malformation. * Severe hematological, hepatic or renal dysfunction (end-stage renal disease on dialysis will not be a contraindication). * Life expectancy \< 1 year * Known or potential hypersensitivity to anticoagulant or antiplatelet drugs or one of the components and/or history of allergic reactions in general, which the Investigator considers important for study participation. * Any evidence of severe or uncontrolled systemic diseases, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardies compliance with the protocol * Females of childbearing potential will be excluded from participation in the study if they meet any one of the following conditions: * are currently pregnant or, * have a positive result on the urine pregnancy test or, * intend to become pregnant during the study treatment period or, • are breast-feeding or, * not willing to use highly effective birth control measures during the entire course of the study treatment period * History of alcohol or drug abuse * Enrollment in another study protocol within 30 days prior to randomization * Any other significant disorders, which, in the opinion of the investigator, may influence the participation in the study or affect study result.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04352218