Angioplasty of Distal Lesions for Carriers of Inoperable Post-embolic HTP
NCT ID: NCT02844036
Last Updated: 2017-10-23
Study Results
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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COMPLETED
NA
33 participants
INTERVENTIONAL
2014-06-30
2017-10-31
Brief Summary
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This study propose an alternative treatment for these patients in therapeutic "dead end". This is about applying arterial thrombosis technique to the pulmonary circulation.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with a pulmonary hypertension
Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
Percutaneous angioplasty
Balloon angioplasty
Right heart catheterization
Echocardiography
A six-minute walking test
Functional respiratory investigations
Pulmonary tomography or pulmonary angiography
Biological parameters
Interventions
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Percutaneous angioplasty
Balloon angioplasty
Right heart catheterization
Echocardiography
A six-minute walking test
Functional respiratory investigations
Pulmonary tomography or pulmonary angiography
Biological parameters
Eligibility Criteria
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Inclusion Criteria
* Patients with a pulmonary hypertension diagnosed by right catheterisation, with a mean arterial pressure \>30 mmHg and arterial pulmonary resistance \> 3 UW.
* Patients with group 4 (Dana point) pulmonary hypertension, thromboembolic.
* Chronic thrombosis visible to scanner, pulmonary IRM angiogram or to pulmonary angiogram.
* Patient's file refused by the reference center multidisciplinary coordination meetings for surgical thromboendartériectomy or refusal from the patient to be operate.
* Absence of counter-argument to the femoral venous or jugular way.
* Normal kidney function or moderatly degraded (clearance\>30 mL) or dialysed renal failure
* Persons affiliated to national social security
* Signed free consent by patients
Exclusion Criteria
* Pulmonary hypertension Group 1 of Dana Point, meaning idiopathic, familial, post-anorectics, associate with a congenital heart disease associated to a scleroderma, associated to a chronic hemolytic disease
* Pulmonary hypertension Group 2 of Dana Point, associated with a left cardiovascular disease
* Pulmonary hypertension Group 3 of Dana Point, associated to a respiratory disease
* Pulmonary hypertension Group 5 of Dana Point, of unclear or multifactorial mechanism
* Hypersensitivity to HEXABRIX, to iodinated contrast product or one of its components
* Obvious thyrotoxicosis
* Protected major persons
* Pregnant or breastfeeding women
* Persons deprived of liberty
* Persons in emergency situations.
* No consent signed or approoved
* Persons no affiliated to national social security
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Hélène Bouvaist, Doctor
Role: PRINCIPAL_INVESTIGATOR
Grenoble Hospital University
Locations
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UniversityHospitalGrenoble
La Tronche, , France
Countries
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References
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Mizoguchi H, Ogawa A, Munemasa M, Mikouchi H, Ito H, Matsubara H. Refined balloon pulmonary angioplasty for inoperable patients with chronic thromboembolic pulmonary hypertension. Circ Cardiovasc Interv. 2012 Dec;5(6):748-55. doi: 10.1161/CIRCINTERVENTIONS.112.971077. Epub 2012 Nov 27.
Sugimura K, Fukumoto Y, Satoh K, Nochioka K, Miura Y, Aoki T, Tatebe S, Miyamichi-Yamamoto S, Shimokawa H. Percutaneous transluminal pulmonary angioplasty markedly improves pulmonary hemodynamics and long-term prognosis in patients with chronic thromboembolic pulmonary hypertension. Circ J. 2012;76(2):485-8. doi: 10.1253/circj.cj-11-1217. Epub 2011 Dec 15.
Fukumoto Y, Shimokawa H. Recent progress in the management of pulmonary hypertension. Circ J. 2011;75(8):1801-10. doi: 10.1253/circj.cj-11-0567. Epub 2011 Jul 11.
Feinstein JA, Goldhaber SZ, Lock JE, Ferndandes SM, Landzberg MJ. Balloon pulmonary angioplasty for treatment of chronic thromboembolic pulmonary hypertension. Circulation. 2001 Jan 2;103(1):10-3. doi: 10.1161/01.cir.103.1.10.
Jais X, D'Armini AM, Jansa P, Torbicki A, Delcroix M, Ghofrani HA, Hoeper MM, Lang IM, Mayer E, Pepke-Zaba J, Perchenet L, Morganti A, Simonneau G, Rubin LJ; Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension Study Group. Bosentan for treatment of inoperable chronic thromboembolic pulmonary hypertension: BENEFiT (Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension), a randomized, placebo-controlled trial. J Am Coll Cardiol. 2008 Dec 16;52(25):2127-34. doi: 10.1016/j.jacc.2008.08.059.
Diggle PJ, Liang KY, Zeger SL. Analysis of longitudinal data. New York: Oxfiord University Press, 2000.
Twisk JWR. Applied longitudinal analysis for epidemiology. Cambridge: Cambridge University Press, 2003.
Mayer E, Jenkins D, Lindner J, D'Armini A, Kloek J, Meyns B, Ilkjaer LB, Klepetko W, Delcroix M, Lang I, Pepke-Zaba J, Simonneau G, Dartevelle P. Surgical management and outcome of patients with chronic thromboembolic pulmonary hypertension: results from an international prospective registry. J Thorac Cardiovasc Surg. 2011 Mar;141(3):702-10. doi: 10.1016/j.jtcvs.2010.11.024.
Pepke-Zaba J, Jansa P, Kim NH, Naeije R, Simonneau G. Chronic thromboembolic pulmonary hypertension: role of medical therapy. Eur Respir J. 2013 Apr;41(4):985-90. doi: 10.1183/09031936.00201612. Epub 2013 Feb 8.
de Perrot M, McRae K, Shargall Y, Pletsch L, Tan K, Slinger P, Ma M, Paul N, Moric J, Thenganatt J, Mak S, Granton JT. Pulmonary endarterectomy for chronic thromboembolic pulmonary hypertension: the Toronto experience. Can J Cardiol. 2011 Nov-Dec;27(6):692-7. doi: 10.1016/j.cjca.2011.09.009. Epub 2011 Oct 21.
Inami T, Kataoka M, Shimura N, Ishiguro H, Yanagisawa R, Taguchi H, Fukuda K, Yoshino H, Satoh T. Pulmonary edema predictive scoring index (PEPSI), a new index to predict risk of reperfusion pulmonary edema and improvement of hemodynamics in percutaneous transluminal pulmonary angioplasty. JACC Cardiovasc Interv. 2013 Jul;6(7):725-36. doi: 10.1016/j.jcin.2013.03.009. Epub 2013 Jun 14.
Other Identifiers
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38RC13.440
Identifier Type: -
Identifier Source: org_study_id