Clinical trial NCT02844036: Angioplasty of Distal Lesions for Carriers of Inoperable Post-embolic HTP
Official title: Angioplasty of Distal Lesions for Carriers of Inoperable Post-embolic HTP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: Distal Lesions
Post-embolic HTP
Angioplasty
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percutaneous angioplasty
timeFrame: About 90 minutes
measure: Balloon angioplasty
timeFrame: About 90 minutes
measure: Right heart catheterization
timeFrame: Few minutes
measure: Echocardiography
timeFrame: Few minutes
measure: Walking test
timeFrame: 6 minutes
measure: Functional respiratory investigations
timeFrame: About an hour
measure: Pulmonary tomography or pulmonary angiography
timeFrame: About 30 minutes
measure: Heart rate
timeFrame: Few minutes
measure: Cardiac output (L/min)
timeFrame: Few minutes
measure: Venous oxygen saturation (%)
timeFrame: Few minutes
measure: Echocardiography
timeFrame: Few minutes
measure: Echocardiography
timeFrame: Few minutes
measure: Walking test
timeFrame: 6 minutes
measure: Walking test
timeFrame: 6 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: La Tronche
country: France
facility: UniversityHospitalGrenoble
Study officials:
affiliation: Grenoble Hospital University
name: Hélène Bouvaist, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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