Intramural HematomaNCT04808661
EndovaScular Versus mediCaL mAnagement of Uncomplicated Type B Intramural heMatoma Trial (ESCLAIM)
A study testing Thoracic endovascular aortic repair plus optimal medical therapy and Optimal medical therapy in people with Intramural Hematoma, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This trial is a multicenter, open-label and prospective randomized controlled study to compare 1-year outcomes of uncomplicated type B intramural hematoma (IMH) patients undergoing thoracic endovascular aortic repair (TEVAR) plus optimal medical therapy (OMT) with that of those undergoing OMT alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intramural Hematoma
- What is being tested?
- Thoracic endovascular aortic repair plus optimal medical therapy and Optimal medical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years;
- Be confirmed as Stanford type B IMH by aorta computed tomography;
- From onset to first clinical attach <90 days;
- The subject or legal guardian understands the nature of the study and agrees to its;
- provisions on a written informed consent form;
- Availability for the appropriate follow-up visits during the follow-up period;
- Capability to follow all study requirements.
Who cannot join
- Persistent or recurrent pain despite full medication,;
- Hemodynamic instability;
- Signs of rupture (periaortic hemorrhage);
- Depth of ULP > 10 mm;
- Aortic diameter > 55 mm;
- ULP around with calcification;
Show all 14Show fewer
- Previous history of aortic-related procedures;
- Blunt thoracic aortic injury;
- Iatrogenic aortic injury;
- Inherited diseases: Turner syndrome, Marfan syndrome, Ehlers-Danlos syndrome, Loeys Dietz syndrome etc.;
- Aortitis: Giant cell arteritis, Takayasu arteritis etc.;
- Patients with malignant tumor whose life expectancy is less than 1 year;
- Intolerance to endotracheal intubation and general anesthesia;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
#106 Dongchuan Second Road, Yuexiu District
Guangzhou, Guangdong, 510000
Fan Yang, MD, 13922783426, 715886618@qq.com
About this study
Official title: Randomized Comparison of Strategies for Uncomplicated Type B Aortic Intramural Hematoma: EndovaScular Versus mediCaL mAnagement of Type B Intramural heMatoma Trial
This trial is a multicenter, open-label and prospective randomized controlled study to compare 1-year outcomes of uncomplicated type B intramural hematoma (IMH) patients undergoing thoracic endovascular aortic repair (TEVAR) plus optimal medical therapy (OMT) with that of those undergoing OMT alone. The primary objective is to test the hypothesis that 1-year aortic-related adverse events are lower in TEVAR plus OMT group than that in OMT alone group. The secondary objective is to test the hypothesis that 1-year all-cause mortality, aortic-related mortality and re-intervention are lower in TEVAR plus OMT group than that in OMT alone group.
Read the detailed description
Intervention group (TEVAR plus OMT): patients will undergo TEVAR besides strict control of blood pressure and heart rate and pain management as mentioned above. According to the preoperative imaging, the potential risk location of the aortic dissection or rupture and the extent of lesion involvement are evaluated, and the appropriate anchoring zone is selected to ensure a sufficient anchorage area of more than 15 mm. If the distance between the potential accident site and the left subclavian artery (LSA) is less than 15 mm, LSA will be covered to obtain sufficient anchoring area. LSA revascularization will be performed by chimney technique or hybrid operation, depending on the choice of the surgeon. The left femoral artery is punctured or cut, the artery sheath is inserted, and the pigtail catheter is inserted into the ascending aorta along the sheath. Next, the aortic covered stent was implanted reverse through the femoral artery under the guidance of the wire. When the stent was released, rapid pacing or intravenous antihypertensive drugs was used to ensure that the blood pressure was lower than 90 mmHg. After stent implantation, re-angiography to confirm the stent location and blood flow, which will indicate whether the operation was successful or not. After all above, the patients will be observed in the hospital for at least 3 days. Controls of the blood pressure and heart rate and relief of the symptoms will meet the discharge criteria.
Conservative group: all patients are under strict control of their blood pressure and heart rate with the guidelines-recommend drugs during hospitalization, including β receptor antagonists with or without other types of antihypertensive drugs if patients can tolerate. The target blood pressure is that systolic blood pressure fluctuates between 100-120 mmHg in the acute and sub-acute phase and blood pressure <130/80 mmHg in the chronic phase. The target heart rate should be limited to 60 bpm in the acute and sub-acute phases. Additionally, pain-releasing drugs ought to be prescribed when needed. Discharge criteria include control of the blood pressure and heart rate and relief of the symptoms.
- Conditions
- Intramural Hematoma
- Being tested
- Thoracic endovascular aortic repair plus optimal medical therapy, Optimal medical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic endovascular aortic repair plus optimal medical therapyProcedure or surgery
Also called TEVAR plus OMT
Endovascular treatment (thoracic endovascular aortic repair) plus optimal medical therapy
Optimal medical therapyDrug
Also called OMT
Optimal medical therapy (strictly control of their blood pressure and heart rate)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Thoracic endovascular aortic repair plus optimal medical therapy Receives: Procedure: Thoracic endovascular aortic repair plus optimal medical therapy |
| Conservative group | Active comparator | Optimal medical therapy Receives: Drug: Optimal medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of aortic-relative events
A composite of hematoma malabsorption, aorta rupture, development of aortic dissection, aortic dilatation (aortic diameter >55 mm) and ulcer-like projection >10 mm in depth.
Measured: One year
Secondary outcomes (3)
Rate of all-cause mortality
All-cause mortality includes aortic-related and nonaortic-related mortality
Measured: One-year
Rate of aortic-related mortality
Aortic-related death was defined as death attributable to an aortic cause during the initial admission or follow-up
Measured: One-year
Incidence of re-intervention
TEVAR plus OMT: secondary intervention; OMT: conversion to intervention.
Measured: One-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Intramural HematomaStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Xinjiang Medical University, The First Affiliated Hospital of Guangzhou Medical University, Jiangmen Central Hospital, Shenzhen People's Hospital, Jieyang People's Hospital, Hanyang University, Henan Provincial Chest Hospital, Xinqiao Hospital of Chongqing
- Responsible party
- Principal investigator, Jianfang Luo, Guangdong Provincial People's Hospital
- Investigators
- Jianfang Luo, MD, Study chair, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808661
- Sponsor's protocol ID
- KY-Q-2021-004-03
- Status last verified
- Jun 2021
- First submitted
- 18 Mar 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohr-Kahaly S, Erbel R, Kearney P, Puth M, Meyer J. Aortic intramural hemorrhage visualized by transesophageal echocardiography: findings and prognostic implications. J Am Coll Cardiol. 1994 Mar 1;23(3):658-64. doi: 10.1016/0735-1097(94)90751-x.
PubMed 8113549Nienaber CA, von Kodolitsch Y, Petersen B, Loose R, Helmchen U, Haverich A, Spielmann RP. Intramural hemorrhage of the thoracic aorta. Diagnostic and therapeutic implications. Circulation. 1995 Sep 15;92(6):1465-72. doi: 10.1161/01.cir.92.6.1465.
PubMed 7664428Evangelista A, Dominguez R, Sebastia C, Salas A, Permanyer-Miralda G, Avegliano G, Gomez-Bosh Z, Gonzalez-Alujas T, Garcia del Castillo H, Soler-Soler J. Prognostic value of clinical and morphologic findings in short-term evolution of aortic intramural haematoma. Therapeutic implications. Eur Heart J. 2004 Jan;25(1):81-7. doi: 10.1016/j.ehj.2003.10.011.
PubMed 14683746Moral S, Cuellar H, Avegliano G, Ballesteros E, Salcedo MT, Ferreira-Gonzalez I, Garcia-Dorado D, Evangelista A. Clinical Implications of Focal Intimal Disruption in Patients With Type B Intramural Hematoma. J Am Coll Cardiol. 2017 Jan 3;69(1):28-39. doi: 10.1016/j.jacc.2016.10.045.
PubMed 28057247Erbel R, Aboyans V, Boileau C, Bossone E, Bartolomeo RD, Eggebrecht H, Evangelista A, Falk V, Frank H, Gaemperli O, Grabenwoger M, Haverich A, Iung B, Manolis AJ, Meijboom F, Nienaber CA, Roffi M, Rousseau H, Sechtem U, Sirnes PA, Allmen RS, Vrints CJ; ESC Committee for Practice Guidelines. 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases: Document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The Task Force for the Diagnosis and Treatment of Aortic Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2014 Nov 1;35(41):2873-926. doi: 10.1093/eurheartj/ehu281. Epub 2014 Aug 29. No abstract available.
PubMed 25173340Nienaber CA, Kische S, Rousseau H, Eggebrecht H, Rehders TC, Kundt G, Glass A, Scheinert D, Czerny M, Kleinfeldt T, Zipfel B, Labrousse L, Fattori R, Ince H; INSTEAD-XL trial. Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial. Circ Cardiovasc Interv. 2013 Aug;6(4):407-16. doi: 10.1161/CIRCINTERVENTIONS.113.000463. Epub 2013 Aug 6.
PubMed 23922146Fattori R, Montgomery D, Lovato L, Kische S, Di Eusanio M, Ince H, Eagle KA, Isselbacher EM, Nienaber CA. Survival after endovascular therapy in patients with type B aortic dissection: a report from the International Registry of Acute Aortic Dissection (IRAD). JACC Cardiovasc Interv. 2013 Aug;6(8):876-82. doi: 10.1016/j.jcin.2013.05.003.
PubMed 23968705Mesar T, Lin MJ, Kabir I, Dexter DJ, Rathore A, Panneton JM. Medical therapy in type B aortic intramural hematoma is associated with a high failure rate. J Vasc Surg. 2020 Apr;71(4):1088-1096. doi: 10.1016/j.jvs.2019.07.084. Epub 2020 Feb 13.
PubMed 32063446Li DL, Zhang HK, Cai YY, Jin W, Chen XD, Tian L, Li M. Acute type B aortic intramural hematoma: treatment strategy and the role of endovascular repair. J Endovasc Ther. 2010 Oct;17(5):617-21. doi: 10.1583/10-3125.1a.
PubMed 20939719Hossack M, Patel S, Gambardella I, Neequaye S, Antoniou GA, Torella F. Endovascular vs. Medical Management for Uncomplicated Acute and Sub-acute Type B Aortic Dissection: A Meta-analysis. Eur J Vasc Endovasc Surg. 2020 May;59(5):794-807. doi: 10.1016/j.ejvs.2019.08.003. Epub 2019 Dec 30.
PubMed 31899101Kitai T, Kaji S, Yamamuro A, Tani T, Kinoshita M, Ehara N, Kobori A, Kita T, Furukawa Y. Impact of new development of ulcer-like projection on clinical outcomes in patients with type B aortic dissection with closed and thrombosed false lumen. Circulation. 2010 Sep 14;122(11 Suppl):S74-80. doi: 10.1161/CIRCULATIONAHA.109.927517.
PubMed 20837929Evangelista A, Dominguez R, Sebastia C, Salas A, Permanyer-Miralda G, Avegliano G, Elorz C, Gonzalez-Alujas T, Garcia Del Castillo H, Soler-Soler J. Long-term follow-up of aortic intramural hematoma: predictors of outcome. Circulation. 2003 Aug 5;108(5):583-9. doi: 10.1161/01.CIR.0000081776.49923.5A. Epub 2003 Jul 21.
PubMed 12874185Evangelista A, Mukherjee D, Mehta RH, O'Gara PT, Fattori R, Cooper JV, Smith DE, Oh JK, Hutchison S, Sechtem U, Isselbacher EM, Nienaber CA, Pape LA, Eagle KA; International Registry of Aortic Dissection (IRAD) Investigators. Acute intramural hematoma of the aorta: a mystery in evolution. Circulation. 2005 Mar 1;111(8):1063-70. doi: 10.1161/01.CIR.0000156444.26393.80. Epub 2005 Feb 14.
PubMed 15710757Piffaretti G, Lomazzi C, Benedetto F, Pipito N, Castelli P, Trimarchi S, Dorigo W, Tozzi M. Best Medical Treatment and Selective Stent-GraftRepair for Acute Type B Aortic Intramural Hematoma. Semin Thorac Cardiovasc Surg. 2018 Autumn;30(3):279-287. doi: 10.1053/j.semtcvs.2018.02.006. Epub 2018 Feb 9.
PubMed 29432889Monnin-Bares V, Thony F, Rodiere M, Bach V, Hacini R, Blin D, Ferretti G. Endovascular stent-graft management of aortic intramural hematomas. J Vasc Interv Radiol. 2009 Jun;20(6):713-21. doi: 10.1016/j.jvir.2009.02.013. Epub 2009 Apr 23.
PubMed 19398351
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Strategies for Uncomplicated Type B Aortic Intramural Hematoma: EndovaScular Versus mediCaL mAnagement of Type B Intramural heMatoma Trial
- ClinicalTrials.gov ID
- NCT04808661
- Acronym / sponsor ID
- KY-Q-2021-004-03
- Conditions
- Intramural Hematoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Xinjiang Medical University, The First Affiliated Hospital of Guangzhou Medical University, Jiangmen Central Hospital, Shenzhen People's Hospital, Jieyang People's Hospital, Hanyang University, Henan Provincial Chest Hospital, Xinqiao Hospital of Chongqing
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a multicenter, open-label and prospective randomized controlled study to compare 1-year outcomes of uncomplicated type B intramural hematoma (IMH) patients undergoing thoracic endovascular aortic repair (TEVAR) plus optimal medical therapy (OMT) with that of those undergoing OMT alone. The primary objective is to test the hypothesis that 1-year aortic-related adverse events are lower in TEVAR plus OMT group than that in OMT alone group. The secondary objective is to test the hypothesis that 1-year all-cause mortality, aortic-related mortality and re-intervention are lower in TEVAR plus OMT group than that in OMT alone group.
Detailed description
Intervention group (TEVAR plus OMT): patients will undergo TEVAR besides strict control of blood pressure and heart rate and pain management as mentioned above. According to the preoperative imaging, the potential risk location of the aortic dissection or rupture and the extent of lesion involvement are evaluated, and the appropriate anchoring zone is selected to ensure a sufficient anchorage area of more than 15 mm. If the distance between the potential accident site and the left subclavian artery (LSA) is less than 15 mm, LSA will be covered to obtain sufficient anchoring area. LSA revascularization will be performed by chimney technique or hybrid operation, depending on the choice of the surgeon. The left femoral artery is punctured or cut, the artery sheath is inserted, and the pigtail catheter is inserted into the ascending aorta along the sheath. Next, the aortic covered stent was implanted reverse through the femoral artery under the guidance of the wire. When the stent was released, rapid pacing or intravenous antihypertensive drugs was used to ensure that the blood pressure was lower than 90 mmHg. After stent implantation, re-angiography to confirm the stent location and blood flow, which will indicate whether the operation was successful or not. After all above, the patients will be observed in the hospital for at least 3 days. Controls of the blood pressure and heart rate and relief of the symptoms will meet the discharge criteria.
Conservative group: all patients are under strict control of their blood pressure and heart rate with the guidelines-recommend drugs during hospitalization, including β receptor antagonists with or without other types of antihypertensive drugs if patients can tolerate. The target blood pressure is that systolic blood pressure fluctuates between 100-120 mmHg in the acute and sub-acute phase and blood pressure <130/80 mmHg in the chronic phase. The target heart rate should be limited to 60 bpm in the acute and sub-acute phases. Additionally, pain-releasing drugs ought to be prescribed when needed. Discharge criteria include control of the blood pressure and heart rate and relief of the symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Thoracic endovascular aortic repair plus optimal medical therapyThoracic endovascular aortic repair plus optimal medical therapy |
| Conservative group | Active comparator | Drug: Optimal medical therapyOptimal medical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 years;
- Be confirmed as Stanford type B IMH by aorta computed tomography;
- From onset to first clinical attach <90 days;
- The subject or legal guardian understands the nature of the study and agrees to its;
- provisions on a written informed consent form;
Key exclusion criteria (14 listed)
- Persistent or recurrent pain despite full medication,;
- Hemodynamic instability;
- Signs of rupture (periaortic hemorrhage);
- Depth of ULP > 10 mm;
- Aortic diameter > 55 mm;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic endovascular aortic repair plus optimal medical therapyAlso: TEVAR plus OMTEndovascular treatment (thoracic endovascular aortic repair) plus optimal medical therapy | Procedure or surgery | Intervention group |
| Optimal medical therapyAlso: OMTOptimal medical therapy (strictly control of their blood pressure and heart rate) | Drug | Conservative group |
Primary outcome
Incidence of aortic-relative events
Time frame: One year
A composite of hematoma malabsorption, aorta rupture, development of aortic dissection, aortic dilatation (aortic diameter >55 mm) and ulcer-like projection >10 mm in depth.
3 secondary outcomes
Rate of all-cause mortality
Time frame: One-year
Rate of aortic-related mortality
Time frame: One-year
Incidence of re-intervention
Time frame: One-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Results publication: PubMed 8113549Mohr-Kahaly S, Erbel R, Kearney P, Puth M, Meyer J. Aortic intramural hemorrhage visualized by transesophageal echocardiography: findings and prognostic implications. J Am Coll Cardiol. 1994 Mar 1;23(3):658-64. doi: 10.1016/0735-1097(94)90751-x.
- Results publication: PubMed 7664428Nienaber CA, von Kodolitsch Y, Petersen B, Loose R, Helmchen U, Haverich A, Spielmann RP. Intramural hemorrhage of the thoracic aorta. Diagnostic and therapeutic implications. Circulation. 1995 Sep 15;92(6):1465-72. doi: 10.1161/01.cir.92.6.1465.
- Results publication: PubMed 14683746Evangelista A, Dominguez R, Sebastia C, Salas A, Permanyer-Miralda G, Avegliano G, Gomez-Bosh Z, Gonzalez-Alujas T, Garcia del Castillo H, Soler-Soler J. Prognostic value of clinical and morphologic findings in short-term evolution of aortic intramural haematoma. Therapeutic implications. Eur Heart J. 2004 Jan;25(1):81-7. doi: 10.1016/j.ehj.2003.10.011.
- Results publication: PubMed 28057247Moral S, Cuellar H, Avegliano G, Ballesteros E, Salcedo MT, Ferreira-Gonzalez I, Garcia-Dorado D, Evangelista A. Clinical Implications of Focal Intimal Disruption in Patients With Type B Intramural Hematoma. J Am Coll Cardiol. 2017 Jan 3;69(1):28-39. doi: 10.1016/j.jacc.2016.10.045.
- Results publication: PubMed 25173340Erbel R, Aboyans V, Boileau C, Bossone E, Bartolomeo RD, Eggebrecht H, Evangelista A, Falk V, Frank H, Gaemperli O, Grabenwoger M, Haverich A, Iung B, Manolis AJ, Meijboom F, Nienaber CA, Roffi M, Rousseau H, Sechtem U, Sirnes PA, Allmen RS, Vrints CJ; ESC Committee for Practice Guidelines. 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases: Document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The Task Force for the Diagnosis and Treatment of Aortic Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2014 Nov 1;35(41):2873-926. doi: 10.1093/eurheartj/ehu281. Epub 2014 Aug 29. No abstract available.
- Results publication: PubMed 23922146Nienaber CA, Kische S, Rousseau H, Eggebrecht H, Rehders TC, Kundt G, Glass A, Scheinert D, Czerny M, Kleinfeldt T, Zipfel B, Labrousse L, Fattori R, Ince H; INSTEAD-XL trial. Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial. Circ Cardiovasc Interv. 2013 Aug;6(4):407-16. doi: 10.1161/CIRCINTERVENTIONS.113.000463. Epub 2013 Aug 6.
- Results publication: PubMed 23968705Fattori R, Montgomery D, Lovato L, Kische S, Di Eusanio M, Ince H, Eagle KA, Isselbacher EM, Nienaber CA. Survival after endovascular therapy in patients with type B aortic dissection: a report from the International Registry of Acute Aortic Dissection (IRAD). JACC Cardiovasc Interv. 2013 Aug;6(8):876-82. doi: 10.1016/j.jcin.2013.05.003.
- Results publication: PubMed 32063446Mesar T, Lin MJ, Kabir I, Dexter DJ, Rathore A, Panneton JM. Medical therapy in type B aortic intramural hematoma is associated with a high failure rate. J Vasc Surg. 2020 Apr;71(4):1088-1096. doi: 10.1016/j.jvs.2019.07.084. Epub 2020 Feb 13.
- Results publication: PubMed 20939719Li DL, Zhang HK, Cai YY, Jin W, Chen XD, Tian L, Li M. Acute type B aortic intramural hematoma: treatment strategy and the role of endovascular repair. J Endovasc Ther. 2010 Oct;17(5):617-21. doi: 10.1583/10-3125.1a.
- Results publication: PubMed 31899101Hossack M, Patel S, Gambardella I, Neequaye S, Antoniou GA, Torella F. Endovascular vs. Medical Management for Uncomplicated Acute and Sub-acute Type B Aortic Dissection: A Meta-analysis. Eur J Vasc Endovasc Surg. 2020 May;59(5):794-807. doi: 10.1016/j.ejvs.2019.08.003. Epub 2019 Dec 30.
- Results publication: PubMed 20837929Kitai T, Kaji S, Yamamuro A, Tani T, Kinoshita M, Ehara N, Kobori A, Kita T, Furukawa Y. Impact of new development of ulcer-like projection on clinical outcomes in patients with type B aortic dissection with closed and thrombosed false lumen. Circulation. 2010 Sep 14;122(11 Suppl):S74-80. doi: 10.1161/CIRCULATIONAHA.109.927517.
- Results publication: PubMed 12874185Evangelista A, Dominguez R, Sebastia C, Salas A, Permanyer-Miralda G, Avegliano G, Elorz C, Gonzalez-Alujas T, Garcia Del Castillo H, Soler-Soler J. Long-term follow-up of aortic intramural hematoma: predictors of outcome. Circulation. 2003 Aug 5;108(5):583-9. doi: 10.1161/01.CIR.0000081776.49923.5A. Epub 2003 Jul 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianfang Luo, MD study chair
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic endovascular aortic repair plus optimal medical therapy and Optimal medical therapy in people with Intramural Hematoma, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fan Yang, MD (13922783426, 715886618@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of aortic-relative events (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04808661, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.