Angioplasty of Distal Lesions for Carriers of Inoperable Post-embolic HTP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Percutaneous angioplasty
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Patients with a pulmonary hypertension
Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
干预措施: Right heart catheterization (Procedure)
Patients with a pulmonary hypertension
Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
干预措施: Echocardiography (Procedure)
Patients with a pulmonary hypertension
Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
干预措施: A six-minute walking test (Other)
Patients with a pulmonary hypertension
Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
干预措施: Functional respiratory investigations (Procedure)
Patients with a pulmonary hypertension
Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
干预措施: Pulmonary tomography or pulmonary angiography (Procedure)
Patients with a pulmonary hypertension
Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
干预措施: Biological parameters (Other)
Patients with a pulmonary hypertension
Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
干预措施: Balloon angioplasty (Procedure)
Patients with a pulmonary hypertension
Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
干预措施: Percutaneous angioplasty (Procedure)
结局指标
主要结局
Percutaneous angioplasty
时间窗: About 90 minutes
International Normalized Ratio wil be measure and need to be between 2 and 3.
Heart rate
时间窗: Few minutes
Heart rate (bpm) during right heart catheterization.
Right heart catheterization
时间窗: 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
时间窗: 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
时间窗: About 90 minutes
Same mode than valscular or coronal angioplasty.
Venous oxygen saturation (%)
时间窗: Few minutes
Venous oxygen saturation (%) during right heart catheterization.
Pulmonary tomography or pulmonary angiography
时间窗: About 30 minutes
tomography (CT) or angiography
Cardiac output (L/min)
时间窗: Few minutes
Cardiac output (L/min) during right heart catheterization.
Echocardiography
时间窗: Few minutes
Right ventricular heart function with evaluation of : - The maximum pressure gradient (mmHg)
Walking test
时间窗: 6 minutes
Start heart rate (T0) and at the end (T6) of the test (bpm)
次要结局
未报告次要终点