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Completed

NCT Number: NCT00657722

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Antoine Beclere, Clamart, France

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About this study

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 %.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Angiography and Computed Tomography

Other

Preoperative angiography and Computed Tomography

Other names: standardized reading grids of APN and ASMD

Primary outcomes

  1. surgical effectiveness evaluated by the death or failure rate.

    Time frame: 6 months

Secondary outcomes

  1. surgical effectiveness evaluated by the death or failure rate.

    Time frame: 3 months

  2. Check that none of the patients considered unresectable on data from staff was declared operable with the criteria predictive success of imaging examinations.

    Time frame: before surgery

  3. Determine the interest of pulmonary angiography in the operability decision compared first to Multi detector AngioCT alone with standardized analyze and then with the both exams.

    Time frame: before surgery

  4. Determine the incidence of adverse events associated with each of these two exams or their combination.

    Time frame: 3 and 6 months after surgery

  5. Check-inter-observer reproducibility of standardized reading grids of pulmonary angiography and MD-AngioCT

    Time frame: Before surgery

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Identification Of The Predictive Angiographic And Computed Tomographic (CT) Criteria Of The Success Of The Thromboendarterectomy In Chronic Pulmonary Hypertension

Acronym: ETHAPE

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 14, 2008
Registry last updated
Apr 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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