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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00657722
• Date of registration: 28/03/2008
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Identification of Criteria of the Success of the Endarterectomy in Chronic Pulmonary Post Embolic Hypertension ETHAPE
• Scientific title: Identification Of The Predictive Angiographic And Computed Tomographic (CT) Criteria Of The Success Of The Thromboendarterectomy In Chronic Pulmonary Hypertension
• Date of first enrolment: January 2008
• Target sample size: 249
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00657722
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Dominique MUSSET, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère

• Name: Gerald SIMONNEAU, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère

• Name: Mathieu LIBERATORE, MD
• Affiliation: Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Thromboembolic Pulmonary Hypertension

Intervention(s)

Other: Angiography and Computed Tomography

Primary Outcome(s)

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

Secondary Outcome(s)

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]

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]

Secondary ID(s)

K060205

Source(s) of Monetary Support

Please refer to primary and secondary sponsors