- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05927090
Outcomes of Type A Aortic Dissection Repair (STAAD)
Surgical Strategy for Repair of Type A Aortic Dissection: A Multicenter Registry
Type A aortic dissection (TAAD) is a potentially life-threatening pathology associated with significant risk of mortality and morbidity. In acute forms of type A aortic dissection (TAAD) mortality is 50% by 24 h and 50% of patients die before reaching a specialist center. Rapid diagnosis and subsequent prompt surgical repair remain the primary goal for these patients.
In the last decade it has been observed that improvements in diagnostic techniques, initial management and increased clinical awareness have contributed to a substantial increase in the number of patients benefiting from a prompt diagnosis and undergoing surgery.However, survival after surgical repair has not yet reached optimal follow-ups and is burdened by high in-hospital mortality(16-18%)
Study Overview
Status
Conditions
Intervention / Treatment
- Procedure: Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair
- Procedure: Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR)
- Procedure: Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP)
- Procedure: Extensive Root and Ascending Aorta Replacement with Total Arch Replacement
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Saint-Denis, France, 93200
- Francesco Nappi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged > 18 years
- TAAD or intramural hematoma involving the ascending aorta
- Symptoms started within 7 days from surgery
- Primary surgical repair of acute TAAD
- Any other major cardiac surgical procedure concomitant with surgery for TAAD.
Exclusion Criteria:
- Patients aged < 18 years
- Onset of symptoms > 7 days from surgery
- Prior procedure for TAAD
- Concomitant endocarditis;
- TAAD secondary to blunt or penetrating chest trauma.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ascending Aorta Replacement (AAR) with or without Hemiarch Repair
Patients who will require a conservative prosthetic replacement of the ascending aorta with or without hemiarch.Patients who required a concomitant aortic valve replacement with conventional xenograft or mechanical prosthesis
|
Cardiac arrest will be performed by administering a potassium-rich antegrade cardioplegia solution delivered directly into the coronary ostium or in the case of aortic regurgitation after insertion of the coronary sinus cannula.The aorta will be resected up to the sinotubular junction and the thrombus located in the false lumen of the aortic root will be removed so that the aortic lesion can be visualized.
The commissures will be resuspended using 4-0 or 5-0 sutures reinforced with a Teflon pledget above every commissure.
A 4-0 or 5-0 polypropylene suture will be chosen to seal the proximal anastomosis and this suture line will also be used to secure the intima to the adventitia.
In patients demonstrating normal-sized aortic roots associated with poor-quality valve leaflets, concomitant aortic valve replacement with conventional xenograft or mechanical prosthesis will be preferable.
Other Names:
|
Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR)
Patient who will require the extensive procedure including ascending aorta replacement associated to root replacement with or without sparing of the aortic valve
|
Patients who experienced dilatation of the sinuses of Valsalva > 4.5 cm in diameter on computed tomography imaging, those with connective tissue disease, or those in whom intimal tears extended into the sinuses, will receive replacement of the aortic root using a biologic or mechanical composite valve graft or valve-sparing root reimplantation procedure associated to AAR
Other Names:
|
Ascending Aorta Replacement with Total Arch Replacement (TARP)
Patient who will require the extensive procedure including ascending aorta replacement associated to TARP
|
Total arch replacement procedures (TARP) will performed with the use of deep hypothermic circulatory arrest and with either antegrade or retrograde cerebral perfusion, maintaining systemic cooling between 19°C to 25°C and depending on the surgeon's practice.TARPs will be carried out using 1- and 4-branch grafts and involved the resection of all the aortic tissue up to the left common carotid artery (total arch)
Other Names:
|
Root and Ascending Aorta Replacement with Total Arch Replacement
Patient who will require the extensive procedure including root and ascending aorta replacement associated to TARP
|
This extensive procedure will include complete replacement of the anterior thoracic aorta extending to part or all of the aortic arch.
It will be performed with the previously reported techniques
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative Mortality (OM)
Time Frame: 30-day
|
Patients who died within 30 days
|
30-day
|
Rate of permanent Neurologic Deficit (PND)
Time Frame: 30-day
|
Number of participants with acute episode of a focal or global neurological deficit.
Rates of alteration of degree of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopsia, amaurosis fugax.
To consider rate of other neurologic signs or symptoms consistent with stroke duration of focal or global neurologic deficit greater than 24 hours.
|
30-day
|
Rate of perioperative Myocardial Infarction (MI)
Time Frame: 30-day
|
Number of participants with MI based on fourth universal definition.
|
30-day
|
Rate of composite of Major Adverse Events (MAE)
Time Frame: 30-day
|
Number of participants with MAE which will include the composite rate of myocardial infarction, cerebrovascular accident, need for dialysis, or need for tracheostomy according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
|
30-day
|
Rate of mesenteric ischemia
Time Frame: 30-day
|
Rate of abdominal pain with or without nausea and vomiting and rectal bleeding or bloody diarrhea
|
30-day
|
Rate of acute heart failure (AHF)
Time Frame: 30-day and in-hospital mortality
|
Number of participants with postoperative AHF who will require prolonged use of concentration of inotropes for a period greater than 24 h and/or the insertion of any mechanical circulatory support device.
|
30-day and in-hospital mortality
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Transient Neurologic Deficit (TND)
Time Frame: 30-day
|
Number of participants who will complicate postoperatively with episode of TND which will include complication rate such as confusion, delirium, agitation
|
30-day
|
Rate of spinal Cord Injury (SCI)
Time Frame: 30-day
|
Number of participants with SCI intended as rate of paraplegia and/or paraparesis
|
30-day
|
Rate of composite of Major Adverse Pulmonary Events (MAPE)
Time Frame: 30-day
|
Number of participants with MAPE which will include the composite rate of intubation >48 hours, pneumonia, reintubation, tracheostomy according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
|
30-day
|
Rate of mechanical circulatory support
Time Frame: 30-day
|
Number of participants who will receive the use of intra-aortic balloon pump and/or venoarterial extracorporeal membrane oxygenation for postoperative acute heart failure.
|
30-day
|
Rate of acute kidney injury
Time Frame: 30-day
|
Number of participants with postoperative change in serum creatinine concentration.
Severity will be stratified on the basis of number of participants with the KDIGO (Kney Disease Improving Global Outcomes) criteria.
|
30-day
|
Rate of perioperative bleeding
Time Frame: 30-day
|
Number of participants who will receive postoperative transfused red blood cell units.
The E-CABG ( coronary artery by pass grafting) classification of bleeding rate has been proposed as a simple classification of perioperative bleeding
|
30-day
|
Reoperation for bleeding
Time Frame: 30-day
|
Number of participants who will receive postoperative chest reopening for excessive bleeding.
|
30-day
|
Rate of reintervention
Time Frame: 18-years
|
The number of participants who will require reoperation for the aortic valve, proximal aorta, or distal aorta.
|
18-years
|
Rate of late survival
Time Frame: 18-years
|
Data on patient's survival status will be collected
|
18-years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of urgent procedure
Time Frame: 30-day
|
Number of participants who will require scheduled procedure within 24 hours of admission.
|
30-day
|
Rate of emergency grade 1
Time Frame: 30-day
|
Number of participants will require procedure within 24 hours of hospital admission and who are symptomatic or minimally symptomatic with stable hemodynamic conditions and no signs of malperfusion.
|
30-day
|
Rate of emergency grade 2
Time Frame: 30-day
|
Number of participants who will require procedure within the first 6 hours of hospital admission due to hemodynamic instability despite use of concentration inotropes and/or malperfusion.
|
30-day
|
Rate of salvage grade 1
Time Frame: 30-day
|
Number of participants who will require immediate surgical procedure.
Rate of cardio pulmonary resuscitation with external chest compressions and/or open cardiac massage between induction of anesthesia and initiation of cardiopulmonary bypass.
|
30-day
|
Rate of salvage grade 2
Time Frame: 30-day
|
Number of participants who will require immediate surgical procedure.
Rate of cardiopulmonary resuscitation with external chest compressions en route to the operating theatre or prior to induction of anesthesia.
|
30-day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Francesco Nappi, MD, Cardiac Surgery Centre Cardiologique du Nord de Saint-Denis, Paris, France
Publications and helpful links
General Publications
- Benedetto U, Dimagli A, Kaura A, Sinha S, Mariscalco G, Krasopoulos G, Moorjani N, Field M, Uday T, Kendal S, Cooper G, Uppal R, Bilal H, Mascaro J, Goodwin A, Angelini G, Tsang G, Akowuah E. Determinants of outcomes following surgery for type A acute aortic dissection: the UK National Adult Cardiac Surgical Audit. Eur Heart J. 2021 Dec 28;43(1):44-52. doi: 10.1093/eurheartj/ehab586.
- Geirsson A, Shioda K, Olsson C, Ahlsson A, Gunn J, Hansson EC, Hjortdal V, Jeppsson A, Mennander A, Wickbom A, Zindovic I, Gudbjartsson T. Differential outcomes of open and clamp-on distal anastomosis techniques in acute type A aortic dissection. J Thorac Cardiovasc Surg. 2019 May;157(5):1750-1758. doi: 10.1016/j.jtcvs.2018.09.020. Epub 2018 Sep 29.
- Harris KM, Nienaber CA, Peterson MD, Woznicki EM, Braverman AC, Trimarchi S, Myrmel T, Pyeritz R, Hutchison S, Strauss C, Ehrlich MP, Gleason TG, Korach A, Montgomery DG, Isselbacher EM, Eagle KA. Early Mortality in Type A Acute Aortic Dissection: Insights From the International Registry of Acute Aortic Dissection. JAMA Cardiol. 2022 Oct 1;7(10):1009-1015. doi: 10.1001/jamacardio.2022.2718.
- Czerny M, Schoenhoff F, Etz C, Englberger L, Khaladj N, Zierer A, Weigang E, Hoffmann I, Blettner M, Carrel TP. The Impact of Pre-Operative Malperfusion on Outcome in Acute Type A Aortic Dissection: Results From the GERAADA Registry. J Am Coll Cardiol. 2015 Jun 23;65(24):2628-2635. doi: 10.1016/j.jacc.2015.04.030.
- O'Hara D, McLarty A, Sun E, Itagaki S, Tannous H, Chu D, Egorova N, Chikwe J. Type-A Aortic Dissection and Cerebral Perfusion: The Society of Thoracic Surgeons Database Analysis. Ann Thorac Surg. 2020 Nov;110(5):1461-1467. doi: 10.1016/j.athoracsur.2020.04.144. Epub 2020 Jun 26.
- Mahase E. Half of patients with acute aortic dissection in England die before reaching a specialist centre. BMJ. 2020 Jan 23;368:m304. doi: 10.1136/bmj.m304. No abstract available.
- Braverman AC. Acute aortic dissection: clinician update. Circulation. 2010 Jul 13;122(2):184-8. doi: 10.1161/CIRCULATIONAHA.110.958975. No abstract available.
- Howard DP, Banerjee A, Fairhead JF, Perkins J, Silver LE, Rothwell PM; Oxford Vascular Study. Population-based study of incidence and outcome of acute aortic dissection and premorbid risk factor control: 10-year results from the Oxford Vascular Study. Circulation. 2013 May 21;127(20):2031-7. doi: 10.1161/CIRCULATIONAHA.112.000483. Epub 2013 Apr 18.
- Biancari F, Juvonen T, Fiore A, Perrotti A, Herve A, Touma J, Pettinari M, Peterss S, Buech J, Dell'Aquila AM, Wisniewski K, Rukosujew A, Demal T, Conradi L, Pol M, Kacer P, Onorati F, Rossetti C, Vendramin I, Piani D, Rinaldi M, Ferrante L, Quintana E, Pruna-Guillen R, Rodriguez Lega J, Pinto AG, Acharya M, El-Dean Z, Field M, Harky A, Nappi F, Gerelli S, Di Perna D, Gatti G, Mazzaro E, Rosato S, Raivio P, Jormalainen M, Mariscalco G. Current Outcome after Surgery for Type A Aortic Dissection. Ann Surg. 2023 Oct 1;278(4):e885-e892. doi: 10.1097/SLA.0000000000005840. Epub 2023 Mar 13.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CN-202201173-3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aortic Valve Insufficiency
-
CSD Labs GmbHCompletedAortic Stenosis | Mitral Insufficiency | Tricuspid Regurgitation | Aortic Insufficiency | Mitral Insufficiency and Aortic Stenosis | Insufficiency, Pulmonary | Insufficiency, TricuspidAustria
-
JenaValve Technology, Inc.Active, not recruitingAortic Valve Disease | Aortic Regurgitation | Aortic Valve Insufficiency | Aortic InsufficiencyUnited States
-
Assistance Publique - Hôpitaux de ParisEuropean Association of Cardiovascular ImagingNot yet recruitingAortic Valve Stenosis | Aortic Valve Disease | Heart Valve Diseases | Mitral Valve Insufficiency | Aortic Valve Insufficiency | Mitral Valve Stenosis | Aortic Valve Stenosis With Insufficiency | Tricuspid Valve Insufficiency | Mitral Valve Disease | Tricuspid Valve Disease | Mitral Valve Insufficiency and... and other conditionsFrance
-
Chengdu Silara Meditech Inc.Not yet recruiting
-
Biostable Science & EngineeringCompletedAortic InsufficiencyGermany, Czech Republic
-
Seung-Jung ParkCardioVascular Research Foundation, KoreaTerminatedAortic Regurgitation | Aortic Valve Insufficiency | Regurgitation, Aortic Valve | Aortic Valve | Aortic IncompetenceKorea, Republic of
-
Michele De BonisCompletedMitral Regurgitation | Aortic RegurgitationItaly
-
Atlantic Health SystemRecruitingMitral Regurgitation | Aortic RegurgitationUnited States
-
Ospedale San RaffaeleUnknownMitral Regurgitation | Aortic RegurgitationItaly
-
Children's Healthcare of AtlantaTerminated
Clinical Trials on Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair
-
Centre Cardiologique du NordUniversita degli Studi di Genova; Campus Bio-Medico University; Henri Mondor... and other collaboratorsEnrolling by invitation
-
Centre Cardiologique du NordUniversita degli Studi di Genova; Henri Mondor University Hospital; Pitié-Salpêtrière... and other collaboratorsEnrolling by invitationAortic Dissection | Aortic Arch | Aortic Dilatation | Aortic Dissection RuptureFrance
-
Triemli HospitalCompletedEndocarditis | Aortic Aneurysm | Aortic Dissection | Valve Heart Disease | Root AbscessSwitzerland
-
Helsinki University Central HospitalAssistance Publique - Hôpitaux de Paris; Universitaire Ziekenhuizen KU Leuven; Azienda Ospedaliera Universitaria Integrata Verona and other collaboratorsActive, not recruitingType A Aortic DissectionSpain, Belgium, Finland, United Kingdom, Germany, Italy, Czechia, France
-
Insel Gruppe AG, University Hospital BernRecruitingAortic Valve Replacement in Patients With Moderate Aortic Stenosis Combined With Mitral RegurgitationSwitzerland
-
University College, LondonSociety for Cardiothoracic Surgery in Great Britain & Ireland; British Congenital...Unknown