Angioplasty of Distal Lesions for Carriers of Inoperable Post-embolic HTP

Not Applicable

Completed

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

• Registration Number: NCT02844036
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-26
• Status Verified: 2017-10
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2017-10-20
• Last Update Posted: 2017-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with a pulmonary hypertension	Biological parameters	Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
Patients with a pulmonary hypertension	Functional respiratory investigations	Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
Patients with a pulmonary hypertension	Percutaneous angioplasty	Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
Patients with a pulmonary hypertension	Balloon angioplasty	Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
Patients with a pulmonary hypertension	Right heart catheterization	Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
Patients with a pulmonary hypertension	A six-minute walking test	Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
Patients with a pulmonary hypertension	Pulmonary tomography or pulmonary angiography	Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
Patients with a pulmonary hypertension	Echocardiography	Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.

Primary Outcome Measures

Name	Time	Method
Heart rate	Few minutes	Heart rate (bpm) during right heart catheterization.
Percutaneous angioplasty	About 90 minutes	International Normalized Ratio wil be measure and need to be between 2 and 3.
Right heart catheterization	Few minutes	Right auricular pressure auriculaire droite moyenne ou POD (mmHg); * Blood pressure : systolic, diastolic, and average(mmHg); * pression artérielle pulmonaire d'occlusion (PAPO) moyenne (mmHg)
Functional respiratory investigations	About an hour	* Forced expiratory volume (FEV) ml/kg; * Forced vital capacity (FVC) ml/kg; * Total lung capacity ml/kg; * Alveolar capillarytransfer of Carbon monoxide (CO) ml/kg; * Transfer coefficient of CO (KCO) ml/kg; All volumes in ml/kg
Balloon angioplasty	About 90 minutes	Same mode than valscular or coronal angioplasty.
Venous oxygen saturation (%)	Few minutes	Venous oxygen saturation (%) during right heart catheterization.
Walking test	6 minutes	Arterial blood saturation in oxygen measured by an oxymeter dat the beginning (T0) and at the end of the test (T6) (SO2)
Echocardiography	Few minutes	Right ventricular heart function with evaluation of : Cardiac output (L/min) and cardiac index (L/min/m²)
Pulmonary tomography or pulmonary angiography	About 30 minutes	tomography (CT) or angiography
Cardiac output (L/min)	Few minutes	Cardiac output (L/min) during right heart catheterization.

Trial Locations

Locations (1)

UniversityHospitalGrenoble; 🇫🇷 La Tronche, France