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

NCT04352218 | Unknown Phase 2 DMC

• 1 other identifier: CO-2018-12367503
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Headache; Jugular Vein Occlusion

Keywords

headache; internal jugular vein obstructive disease and malformation; PTA; Stenting

Outcome Measures

Primary Outcomes (2)

• Safety: Device related adverse events

  The safety is assessed by a composite of freedom from device migration and fracture, and rupture and bleeding of the target vein within 12 months post-index procedure. 1. Migration is defined as the displacement of the investigational device from the site of stenotic IJV tract towards the brain or anonymous trunk and right atrium and is investigated by X-radiations, DUS and CTA (if needed) through 30 days. 2. Fracture of the Petalo's scaffold is defined as the rupture of the main modules or the bridge connections evaluated by X-radiations and CTA of the neck through 30, 90, 180 and 360 days. 3. Bleeding is defined as a perforation of the target IJV determining an hematoma in the neck at the site of IJV stenting, and is investigated by DUS and CTA through 30, 90, 180 and 360 days.

  12 months

• Efficacy: Stent delivery and Primary Patency

  1. Successful delivery and positioning of the Petalo CVS stent are defined as the precise delivery of investigational device at the site of stenotic Internal Jugular vein tract, evaluated by X-radiations, and DUS examinations through 30 days post-index procedure; 2. Primary patency of Petalo's stent and of the target internal jugular vein is defined as freedom from stenosis \> 70% of the investigational medical device and of target vein investigated by Duplex Ultrasound and CTA (in case of stenosis), through 30, 90, 180 and 360 days post-index procedure.

  12 months

Secondary Outcomes (2)

• Chronic Migraine is assessed by "Migraine Disability Assessment Score" (MIDAS).

  12 months

• Major adverse events: composite of freedom from device and procedure-related mortality

  12 months

Study Arms (2)

PTA Percutaneous Transluminal Angioplasty

ACTIVE COMPARATOR

Percutaneous Transluminal Angioplasty of internal jugular vein non-thrombotic stenosis in patients with chronic headache

Procedure: Percutaneous Transluminal Angioplasty (PTA)

PTA + Stenting using "Petalo stent"

EXPERIMENTAL

Percutaneous Transluminal Angioplasty + Stenting of internal jugular vein non-thrombotic stenosis in patients with chronic headache

Device: PTA + Stenting using "Petalo stent"

Interventions

PTA + Stenting using "Petalo stent" DEVICE

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.

Also known as: Petalo's stenting of Internal Jugular Veins

PTA + Stenting using "Petalo stent"

Percutaneous Transluminal Angioplasty (PTA) PROCEDURE

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

Also known as: Venoplasty of Internal Jugular Veins

PTA Percutaneous Transluminal Angioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University of Catania: lead

Related Publications (14)

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• Jensen RH, Radojicic A, Yri H. The diagnosis and management of idiopathic intracranial hypertension and the associated headache. Ther Adv Neurol Disord. 2016 Jul;9(4):317-26. doi: 10.1177/1756285616635987. Epub 2016 Mar 21.

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• Zhou D, Meng R, Zhang X, Guo L, Li S, Wu W, Duan J, Song H, Ding Y, Ji X. Intracranial hypertension induced by internal jugular vein stenosis can be resolved by stenting. Eur J Neurol. 2018 Feb;25(2):365-e13. doi: 10.1111/ene.13512. Epub 2017 Dec 7.

  PMID: 29114973 BACKGROUND

• Bavera, M. May symptoms of chronic cerebrospinal venous insufficiency be improved by venous angioplasty? An independent 4-year follow up on 366 cases," Veins & Lymphatics, vol. 4, p. 5400, 2015

  BACKGROUND

• Bono F, Messina D, Giliberto C, Cristiano D, Broussard G, D'Asero S, Condino F, Mangone L, Mastrandrea C, Fera F, Quattrone A. Bilateral transverse sinus stenosis and idiopathic intracranial hypertension without papilledema in chronic tension-type headache. J Neurol. 2008 Jun;255(6):807-12. doi: 10.1007/s00415-008-0676-2. Epub 2008 May 6.

  PMID: 18458863 BACKGROUND

• Chung CP, Chao AC, Hsu HY, Lin SJ, Hu HH. Decreased jugular venous distensibility in migraine. Ultrasound Med Biol. 2010 Jan;36(1):11-6. doi: 10.1016/j.ultrasmedbio.2009.08.007.

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  PMID: 19958985 BACKGROUND

• Zamboni P, Galeotti R, Weinstock-Guttman B, Kennedy C, Salvi F, Zivadinov R. Venous angioplasty in patients with multiple sclerosis: results of a pilot study. Eur J Vasc Endovasc Surg. 2012 Jan;43(1):116-22. doi: 10.1016/j.ejvs.2011.03.035. Epub 2011 Aug 11.

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• Lee BB, Baumgartner I, Berlien P, Bianchini G, Burrows P, Gloviczki P, Huang Y, Laredo J, Loose DA, Markovic J, Mattassi R, Parsi K, Rabe E, Rosenblatt M, Shortell C, Stillo F, Vaghi M, Villavicencio L, Zamboni P. Guideline. Diagnosis and treatment of venous malformations. consensus document of the international union of phlebology (iup): updated-2013. Int Angiol. 2014 Jun 10. Online ahead of print.

  PMID: 24961611 BACKGROUND

• Veroux P, Giaquinta A, Virgilio C, Zani DD, Ravasio G, Ardita V, Secchiero P, Scanziani E, Zamboni P, Veroux M. Novel Compliant Scaffold with Specific Design for Venous System: Results of a Porcine Model Study. Biomed Res Int. 2018 Jan 31;2018:7312315. doi: 10.1155/2018/7312315. eCollection 2018.

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• Stewart WF, Lipton RB, Dowson AJ, Sawyer J. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology. 2001;56(6 Suppl 1):S20-8. doi: 10.1212/wnl.56.suppl_1.s20.

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• Zamboni P, Giaquinta A, Rimondi E, Pedriali M, Scanziani E, Riccaboni P, Veroux M, Secchiero P, Veroux P. A novel endovenous scaffold for the treatment of chronic venous obstruction in a porcine model: Histological and ultrastructural assessment. Phlebology. 2019 Jun;34(5):336-346. doi: 10.1177/0268355518805686. Epub 2018 Oct 18.

  PMID: 30336762 BACKGROUND

MeSH Terms

Conditions

Headache; Congenital Abnormalities

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Veroux Pierfrancesco, MD

  University of Catania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veroux Pierfrancesco

CONTACT

+39 3476601160; info@petalo4vein.com

Mirko Tomasino - Chiara Veroux

CONTACT

+39 0953782946; info@petalo4vein.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of vascular and transplantation surgery

Model Details: To prospective collect and assess safety and efficacy data on the "Petalo trial" in the treatment of patients with non-thrombotic internal jugular vein stenosis and chronic headache poor responder to best medical therapy.

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: April 20, 2020
• Study Start: September 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2022
• Last Updated: June 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share