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

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

Headache

Jugular Vein Occlusion

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.

PTA + Stenting using "Petalo stent"

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

Percutaneous Transluminal Angioplasty (PTA)

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

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

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.
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.
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.
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.

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;
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.

The questionnaire "Migraine Disability Assessment Score" MIDAS is administered before the index procedure, and through 1, 3, 6, 12 months. The severity of migraine is defined as the following scores:
Little or No Disability: 0-5 score;
Mild Disability: 6-10 score;
Moderate Disability:11-20 score;
Severe Disability: > 20.

MAEs is defined as all-cause mortality, and thrombosis at the target lesion site.
All-cause mortality are assessed and documented at 30 days, 6, 12 months.
Thrombosis is defined as the complete occlusion of the Petalo stent at the target lesion site, documented by DUS investigation at 30 days, 6, 12 months.

PIERFRANCESCO VEROUX

Professor of vascular and transplantation surgery

University of Catania

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.

The cohort comprises of patients who are diagnosed to have chronic kidney disease as defined by the K/DOQI Clinical Practice Guidelines for Chronic Kidney Disease-2002.

pseudotumor cerebri/vomito

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

Disc Edema in Patients With Chronic Kidney Disease

High/Low Dose Vit A in Diarrhea/ALRI in Severe PEM

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