Identification of Criteria of the Success of the Endarterectomy in Chronic Pulmonary Post Embolic Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-11-30

Brief Summary

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In order to improve effectiveness of the surgical operation thanks to a reduction in the rate of failure, this study will allow us to identify predictive angiographic and CT finding of surgical failure, starting from standardized reading grids, in order to have a better selection of the operable patients.

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Detailed Description

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Chronic thromboembolic pulmonary hypertension(CTEPH) is caused by obstruction of the large pulmonary arteries by acute and recurrent pulmonary emboli, and organization of these blood clots. ANTOINE BECLERE respiratory unit, in partnership with the MARIE LANNELONGUE hospital thoracic and vascular surgery departments was designated recently as reference national centre for pulmonary hypertension and represents the only French structure for evaluation of CTEPH with 150 patients addressed each year.If the disease is proximately located, CTEPH can be cured surgically through a complex surgical procedure performed under Hypothermia and total circulatory arrest. In spite of multidisciplinary meeting deciding the operability of each case the rate of failure is approximately of 15% (9% of operative mortality rate and 6% of technical failure).

The aim of this study is to identify predictive angiographic and CT findings of success, by allowing a better selection of operable patients.

It would be possible to improve the effectiveness of the surgical treatment and reduce the rate failure from 15% to 7 % or even 5 %.

Conditions

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Chronic Thromboembolic Pulmonary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Angiography and Computed Tomography

Group Type EXPERIMENTAL

Angiography and Computed Tomography

Intervention Type OTHER

Preoperative angiography and Computed Tomography

Interventions

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Angiography and Computed Tomography

Preoperative angiography and Computed Tomography

Intervention Type OTHER

Other Intervention Names

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standardized reading grids of APN and ASMD

Eligibility Criteria

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Inclusion Criteria

* Patients addressed to the reference centre of pulmonary hypertension for a suspected CPC-PE
* Achieving an assessment prior to the operation, including:1) Right cardiac catheterization confirming HTP with a mean pulmonary arterial pressure\> 25 mm Hg at rest; 2) Echography and Doppler of the lower limbs in search of phlebitis sequela; 3) Pulmonary scintigraphy with 6 views in ventilation and perfusion; 4) Digital pulmonary angiography; 5) A 64 detector pulmonary computed tomography; 6) Having read the briefing note and given their agreement.

Exclusion Criteria

* Refusal examinations .
* Patient for which one method is contraindicated
* Patient considered not operable by the staff
* Life expectancy of less than 3 months
* Geographical distance for the clinical follow-up at 3 months
* Renal insufficiency (creatinine clearance \<30 mL / min)
* Proven allergy to iodinated contrast agents
* Pregnant woman.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No