Angioplasty of Distal Lesions for Carriers of Inoperable Post-embolic HTP (OCT²EPH)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Pulmonary Hypertension

Treatments: Procedure: Percutaneous angioplasty; Procedure: Functional respiratory investigations; Procedure: Balloon angioplasty; Procedure: Echocardiography; Other: A six-minute walking test; Procedure: Right heart catheterization; Other: Biological parameters; Procedure: Pulmonary tomography or pulmonary angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT02844036

38RC13.440

Details and patient eligibility

About

Currently, the standard treatment for proximal thromboses lesions responsible for post-embolic pulmonary hypertension, is the surgical thromboendarterectomy. When the ravages are judged too distal or the patient is judged inoperable for a curative surgical gesture, there is no evidence of any therapeutic option, exept for K anti-vitamins for recurrent embolism. Prognosis is then pejorative with a 60% mortality at 5 years.

This study propose an alternative treatment for these patients in therapeutic "dead end". This is about applying arterial thrombosis technique to the pulmonary circulation.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years
• Patients with a pulmonary hypertension diagnosed by right catheterisation, with a mean arterial pressure >30 mmHg and arterial pulmonary resistance > 3 UW.
• Patients with group 4 (Dana point) pulmonary hypertension, thromboembolic.
• Chronic thrombosis visible to scanner, pulmonary IRM angiogram or to pulmonary angiogram.
• Patient's file refused by the reference center multidisciplinary coordination meetings for surgical thromboendartériectomy or refusal from the patient to be operate.
• Absence of counter-argument to the femoral venous or jugular way.
• Normal kidney function or moderatly degraded (clearance>30 mL) or dialysed renal failure
• Persons affiliated to national social security
• Signed free consent by patients

Exclusion criteria

• Pulmonary hypertension pos-embolic operated by thromboendarteriectomy
• Pulmonary hypertension Group 1 of Dana Point, meaning idiopathic, familial, post-anorectics, associate with a congenital heart disease associated to a scleroderma, associated to a chronic hemolytic disease
• Pulmonary hypertension Group 2 of Dana Point, associated with a left cardiovascular disease
• Pulmonary hypertension Group 3 of Dana Point, associated to a respiratory disease
• Pulmonary hypertension Group 5 of Dana Point, of unclear or multifactorial mechanism
• Hypersensitivity to HEXABRIX, to iodinated contrast product or one of its components
• Obvious thyrotoxicosis
• Protected major persons
• Pregnant or breastfeeding women
• Persons deprived of liberty
• Persons in emergency situations.
• No consent signed or approoved
• Persons no affiliated to national social security

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Patients with a pulmonary hypertension

Experimental group

Description:

Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.

Treatment:

Procedure: Functional respiratory investigations

Procedure: Percutaneous angioplasty

Procedure: Echocardiography

Other: A six-minute walking test

Procedure: Right heart catheterization

Procedure: Pulmonary tomography or pulmonary angiography

Procedure: Balloon angioplasty

Other: Biological parameters