Identification of Criteria of the Success of the Endarter... | NCT00657722

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

NCT00657722

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Apr 11, 2013Estimated

Enrollment

249Actual

Phase

Not Applicable

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Interventions

Angiography and Computed Tomography

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jul 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Mar 28, 2008

First Submission Date that Met QC Criteria

Apr 11, 2008

First Posted Date

Apr 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2013

Last Update Posted Date

Apr 11, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 Description

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 %.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

249Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Angiography and Computed Tomography	Other: Angiography and Computed Tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Angiography and Computed Tomography	Other	Preoperative angiography and Computed Tomography	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
surgical effectiveness evaluated by the death or failure rate.		6 months

Secondary Outcomes

Measure	Description	Time Frame
surgical effectiveness evaluated by the death or failure rate.		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.		before surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mathieu LIBERATORE, MD	Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère	Principal Investigator
Dominique MUSSET, MD, PhD	Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère	Study Director
Gerald SIMONNEAU, MD, PhD	Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Antoine Beclere		Clamart		92141	France
Hospital Marie Lannelongue

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided