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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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 %.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: surgical effectiveness evaluated by the death or failure rate. [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • surgical effectiveness evaluated by the death or failure rate. [ Time Frame: 3 months ]
  • 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 ]
  • 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 ]
  • Determine the incidence of adverse events associated with each of these two exams or their combination. [ Time Frame: 3 and 6 months after surgery ]
  • Check-inter-observer reproducibility of standardized reading grids of pulmonary angiography and MD-AngioCT [ Time Frame: Before surgery ]


Original Secondary Outcome:

  • surgical effectiveness evaluated by the death or failure rate. [ Time Frame: 3 months ]
  • 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 ]
  • Determine the square of the NPC in the balance usability compared with the ASMD comparing one hand, the decision to read standardized operability of the AMD-64 cuts with that of the NPC and with that of the association of two exams [ Time Frame: before surgery ]
  • Determine the incidence of adverse events associated with each of these two exams or their combination. [ Time Frame: 3 and 6 months after surgery ]
  • Check-inter-observer reproducibility of standardized reading grids of APN and ASMD [ Time Frame: Before surgery ]


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: March 28, 2008
Date Started: January 2008
Date Completion:
Last Updated: April 10, 2013
Last Verified: April 2013