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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with a pulmonary hypertension<br>Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic. | Procedure: Percutaneous angioplasty<br> <br> Procedure: Balloon angioplasty<br> <br> Procedure: Right heart catheterization<br> <br> Procedure: Echocardiography<br> <br> Other: A six-minute walking test<br> <br> Procedure: Functional respiratory investigations<br> <br> Procedure: Pulmonary tomography or pulmonary angiography<br> <br> Other: Biological parameters<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percutaneous angioplasty | International Normalized Ratio wil be measure and need to be between 2 and 3. | About 90 minutes | 
| Balloon angioplasty | Same mode than valscular or coronal angioplasty. | About 90 minutes | 
| Right heart catheterization | Right auricular pressure auriculaire droite moyenne ou POD (mmHg) Blood pressure : systolic, diastolic, and average(mmHg) pression artérielle pulmonaire d'occlusion (PAPO) moyenne (mmHg) | Few minutes | 
| Echocardiography | Right ventricular heart function with evaluation of : - The maximum pressure gradient (mmHg) | Few minutes | 
| Walking test | Start heart rate (T0) and at the end (T6) of the test (bpm) | 6 minutes | 
| Functional respiratory investigations | 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 | About an hour | 
| Pulmonary tomography or pulmonary angiography | tomography (CT) or angiography | About 30 minutes | 
| Heart rate | Heart rate (bpm) during right heart catheterization. | Few minutes | 
| Cardiac output (L/min) | Cardiac output (L/min) during right heart catheterization. | Few minutes | 
| Venous oxygen saturation (%) | Venous oxygen saturation (%) during right heart catheterization. | Few minutes | 
| Echocardiography | Right ventricular heart function with evaluation of : Surface area of the right ventricle (cm²) | Few minutes | 
| Echocardiography | Right ventricular heart function with evaluation of : Cardiac output (L/min) and cardiac index (L/min/m²) | Few minutes | 
| Walking test | Patient self evaluation of the dyspnea on a Borg scale from 0 (not breathless) to 10 (serious breathless) | 6 minutes | 
| Walking test | Arterial blood saturation in oxygen measured by an oxymeter dat the beginning (T0) and at the end of the test (T6) (SO2) | 6 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal Lesions, Post-embolic HTP, Angioplasty