Scandinavian Trial of Uncomplicated Aortic Dissection Therapy
NCT ID: NCT05215587
Last Updated: 2025-08-11
Study Results
Results pending
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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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
554 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-05-24
Study Completion Date
2030-12-31
Brief Summary
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The introduction of thoracic endovascular aortic repair (TEVAR) in 1994 has radically changed the treatment of thoracic aortic pathology, and TEVAR is now the recommended therapy for "complicated" TBADs and other thoracic aorta diseases. To date, the use of TEVAR in the treatment of "uncomplicated" dissections (uTBAD) is uncertain, although it is presumed that a prophylactic procedure can prevent later complex surgery and early death. Several analyses have found that TEVAR confers improved aortic remodeling and possibly survival, although these were underpowered for this specific outcome. In addition, there are several reports regarding the uncertain benefit or harm of this intervention in the vascular surgery community. Put another way, there is equipoise, and the need for robust evidence in the form of a randomized clinical trial has been clearly iterated by the European Society of Vascular Surgery.
This randomized, open-label, two-armed controlled study directly addresses this question of whether TEVAR alters 5-year survival among patients with an uTBAD. Patients will be randomized to either standard medical therapy (SMT) alone or TEVAR in addition to SMT. The primary outcome is 5-year survival, while secondary outcomes include aortic-related mortality, neurological events, quality of life, costs, re interventions and readmissions. in addition, subgroup analyses based on the extent of treatment.
Sample size calculations based on previous reports indicate the need to include approximately 554 patients. Patients will be recruited from multiple centres in Scandinavia. Based on the population (24 million) and incidence of uTBAD (approximately 480 per year), and depending on the total number of participating centres, a conservative estimate of two to three years is required for enrolment.
This randomized, open-label, two-armed controlled study directly addresses this question of whether TEVAR alters 5-year survival among patients with an uTBAD. Patients will be randomized to either standard medical therapy (SMT) alone or TEVAR in addition to SMT. The primary outcome is 5-year survival, while secondary outcomes include aortic-related mortality, neurological events, quality of life, costs, re interventions and readmissions. in addition, subgroup analyses based on the extent of treatment.
Sample size calculations based on previous reports indicate the need to include approximately 554 patients. Patients will be recruited from multiple centres in Scandinavia. Based on the population (24 million) and incidence of uTBAD (approximately 480 per year), and depending on the total number of participating centres, a conservative estimate of two to three years is required for enrolment.
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ACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy
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Detailed Description
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This randomized, open-label, two-armed controlled study addresses the question of whether thoracic endovascular aortic repair (TEVAR) alters 5-year survival among patients with an uncomplicated Stanford type-B aortic dissection (uTBAD). Patients will be randomized to either standard medical therapy (SMT) alone or TEVAR in addition to SMT. The primary outcome is 5-year survival, while secondary outcomes include aortic-related mortality, neurological events, quality of life, costs, re interventions and readmissions. in addition, subgroup analyses based on the extent of treatment.
Primary hypothesis:
The null hypothesis for this trial states that the five-year survival results for patients treated with either SMT or SMT + TEVAR are equivalent.
2\. Background
The incidence of a Stanford type-B thoracic aortic dissection (TBAD) is estimated at 3.9 - 6.0 per 100,000 person years, although this may be an underestimate. These account for approximately 30-40% of all types of aorta dissection. The diagnosis of TBAD is further classified with respect to time: acute, ≤ 14 days, subacute, 15-90 days, and chronic, \> 90 days. Approximately 40-50% of ABDs are considered complicated which, according to the European Society of Vascular Surgery, is defined as the presence of one or more of the following: rupture and/or hypotension/shock, organ malperfusion, rapid aortic expansion, paraplegia/paraparesis, peri-aortic haematoma, or intractable pain or hypertension. In the absence of these complications, the dissection is considered uncomplicated. In-hospital survival for these patients has been reported as approximately 90%.
The management of TBADs is dependent upon the above-mentioned factors, i.e., complicated or uncomplicated, acute or chronic, as well as accompanying comorbidities. An underlying and universal component for all these patients is optimal medical therapy, which includes antihypertensive therapy, typically beta-blockers, in order to mitigate aortic wall stress and false lumen pressures, as well as pain relief. Furthermore, lifestyle improvements and cardiovascular risk profile modification are recommended.
The introduction of thoracic endovascular aortic repair (TEVAR) in 1994 radically changed the treatment of thoracic aortic pathology, and TEVAR is now the recommended therapy for complicated TBADs, thoracic aortic aneurysms, and traumatic thoracic transections, among others. To date, the use of TEVAR in the treatment of uncomplicated TBAD is uncertain, if not controversial. Several analyses have found that TEVAR confers improved aortic remodeling and possibly survival, albeit with the implied and inherent procedural risks of intervention, including paraplegia, retrograde dissection, and death.
There are two relevant randomized clinical trials (RCTs), addressing the issue of early TEVAR among TBAD patients. The Acute Dissection: Stent graft OR Best medical therapy (ADSORB) trial, notably underpowered, randomized a total of 61 patients from 17 European centres with acute uTBAD. There were no aortic ruptures at 1-year in either arm of the trial, while TEVAR was associated with improved thrombosis of the false lumen and reduction of its lumen. The Investigation of Stent Grafts in Aortic Dissection (INSTEAD) trial included 140 patients in the subacute phase. The overall survival at two years was statistically equivalent, 95.6% in the medical arm and 88.9% in the TEVAR plus medicine group. The long-terms results from the extended INSTEAD-XL found a non-significant absolute reduction in all-cause mortality of 8.2% at five years for those patients who underwent TEVAR.
The conclusions from the retrospective and above-mentioned RCTs have not been persuasive enough for the European Society of Vascular Surgery to render a higher recommendation than "TEVAR may be selectively considered" for those patients presenting with uncomplicated type B aortic dissections. This is furthermore echoed by a recent international survey regarding preferred treatment of uTBAD, in which 54.8% of respondents answered that they do not routinely use TEVAR, as opposed to 37.4% who prefer this strategy; moreover, 88.6% of respondents agreed that equipoise was present and that an RCT was warranted.
Research Objectives
Primary Objective
• To compare the overall survival at five years between subjects treated with SMT or SMT + subacute TEVAR.
Secondary Objectives
* To compare the risk of aortic-related mortality.
* To compare the risk of neurological injury, including stroke or paraplegia.
* To compare the proportion and indication of subjects who underwent an aortic intervention within 5 years due to development of an aortic complication.
* To compare the number of disease-related readmissions during follow-up.
* To compare, based on subgroup analyses, whether extent of TEVAR is associated with either improved survival or neurological injury.
* To compare the associated risk of reinterventions, including those subjects who were initially randomized to SMT and subsequently required an aortic intervention.
* To compare the associated changes in quality-of-life.
* To compare the 10-year overall survival and aortic-related mortality.
* To compare the costs.
Endpoint Definitions
Primary endpoint:
All-cause mortality.
Secondary endpoints:
Aortic-related mortality: Death as a result from aortic rupture or organ malperfusion, or death due to aortic intervention.
Aortic intervention: Any open surgical or endovascular intervention performed in any anatomical location, performed for the following indications, which are related to the aortic pathology: aneurysmal degeneration, visceral ischemia, lower extremity ischemia, rupture, or any of the criteria listed above under the definition of a complicated TBAD.
Neurological injury: These are divided into two categories: cerebrovascular accidents (CVA) and spinal cord ischemia (SCI). CVAs are defined according to the Society for Vascular Surgery reporting standards and classified as any central neurological complication, ischemic and hemorrhagic. For this project, the modified Rankin scale will be used for classifying stroke severity. Spinal cord ischemia is defined as either ischemic or hemorrhagic resulting in paraparesis or paraplegia. The modified Tarlov scoring scale will be used for the grading of any spinal cord injuries.
Reintervention: Any open or endovascular intervention after the original TEVAR procedure that was related to the dissection. These should be categorized as either planned reintervention, e.g., a staged procedure, or unplanned, which indicates a complication from the original procedure, a failure of the device, or progression of disease.
Quality of life: The quality of life will be assessed with the three following self-assessment forms:
1. The EuroQOL-5D-5L instrument from the EuroQol Group, comprised of five dimensions with five levels of scoring that can be combined into a five-digit number of description.
2. The Hospital and Anxiety Depression Score (HADS).
3. The 12-Item Short-Form (12-SF) Health Survey.
Economic evaluation: The economic evaluation will be performed from a payer/healthcare point of view, including resource use associated with healthcare, intervention and medication, whereas broader potential consequences for society, i.e., effects on productivity, will not be included. During the course of the trial, the accumulated costs will be measured per treatment arm from the participating hospital´s administrative/controlling/billing systems. As far as possible, the following resource use items will be included and captured as accumulated costs from the hospital's cost-per- subject system on all outpatient and inpatient visits:
* costs for healthcare staff
* subject -specific costs for primary and secondary endovascular and surgical procedures postoperative care unit costs
* costs of drugs during surgery and postoperative care
* costs of anaesthetic procedures and blood transfusions
* additional diagnostic procedures from the radiology and clinical physiology departments and from clinical chemistry.
The costs for healthcare staff will comprise the full wage costs, including costs for social security. Costs for each endovascular and surgical procedure will be retrieved individually, and, as far as possible, be based on the price per minute according to the hospital's cost-per- subject systems.
Changes in health status will be assessed in terms of quality-adjusted life-years (QALYs), which combine the time spent in a specific health state with the corresponding self-assessed health-related quality of life (HRQoL), as derived from the EuroQOL EQ-5D-5L questionnaire. Time is measured in years and the HRQoL is measured on an index scale ranging from 0 (equivalent to being dead) to 1 (best possible health state). The total number of QALYs will be calculated by multiplying the HRQoL index score (QALY weight) by the time spent in each health state. Group differences in total costs will be calculated and divided by the difference in QALYs in the interval from baseline until end of study, and the incremental cost-effectiveness ratio will be calculated as follows:
(CostTEVAR -CostSMT)/(QALYsTEVAR - QALYsSMT)=ΔCost/ΔQALY.
Rationale for objectives and endpoint selection
Despite evidence from retrospective and descriptive studies suggesting long-term benefits for early TEVAR intervention among uTBAD subjects, the underlying unanswered question is whether TEVAR confers a benefit of survival. The two previous RCTs, mentioned above, were underpowered to address this issue. Despite potential theoretical and procedural advantages of various composite endpoints, it was determined that a trial based on a clearly expressed question with a binary outcome will have the most clinical impact. Similarly, focus on the albeit interesting, but not essential, endpoint of aortic morphological changes and imaging findings, would complicate the pragmatic design of this trial.
Study Design
The trial is a randomized, open label, clinical trial with parallel assignment of subjects in multiple sites in Denmark, Sweden, Norway, Iceland, and Finland. Recruited subjects will be randomized to either SMT exclusively or TEVAR + SMT.
Primary hypothesis:
The null hypothesis for this trial states that the five-year survival results for patients treated with either SMT or SMT + TEVAR are equivalent.
2\. Background
The incidence of a Stanford type-B thoracic aortic dissection (TBAD) is estimated at 3.9 - 6.0 per 100,000 person years, although this may be an underestimate. These account for approximately 30-40% of all types of aorta dissection. The diagnosis of TBAD is further classified with respect to time: acute, ≤ 14 days, subacute, 15-90 days, and chronic, \> 90 days. Approximately 40-50% of ABDs are considered complicated which, according to the European Society of Vascular Surgery, is defined as the presence of one or more of the following: rupture and/or hypotension/shock, organ malperfusion, rapid aortic expansion, paraplegia/paraparesis, peri-aortic haematoma, or intractable pain or hypertension. In the absence of these complications, the dissection is considered uncomplicated. In-hospital survival for these patients has been reported as approximately 90%.
The management of TBADs is dependent upon the above-mentioned factors, i.e., complicated or uncomplicated, acute or chronic, as well as accompanying comorbidities. An underlying and universal component for all these patients is optimal medical therapy, which includes antihypertensive therapy, typically beta-blockers, in order to mitigate aortic wall stress and false lumen pressures, as well as pain relief. Furthermore, lifestyle improvements and cardiovascular risk profile modification are recommended.
The introduction of thoracic endovascular aortic repair (TEVAR) in 1994 radically changed the treatment of thoracic aortic pathology, and TEVAR is now the recommended therapy for complicated TBADs, thoracic aortic aneurysms, and traumatic thoracic transections, among others. To date, the use of TEVAR in the treatment of uncomplicated TBAD is uncertain, if not controversial. Several analyses have found that TEVAR confers improved aortic remodeling and possibly survival, albeit with the implied and inherent procedural risks of intervention, including paraplegia, retrograde dissection, and death.
There are two relevant randomized clinical trials (RCTs), addressing the issue of early TEVAR among TBAD patients. The Acute Dissection: Stent graft OR Best medical therapy (ADSORB) trial, notably underpowered, randomized a total of 61 patients from 17 European centres with acute uTBAD. There were no aortic ruptures at 1-year in either arm of the trial, while TEVAR was associated with improved thrombosis of the false lumen and reduction of its lumen. The Investigation of Stent Grafts in Aortic Dissection (INSTEAD) trial included 140 patients in the subacute phase. The overall survival at two years was statistically equivalent, 95.6% in the medical arm and 88.9% in the TEVAR plus medicine group. The long-terms results from the extended INSTEAD-XL found a non-significant absolute reduction in all-cause mortality of 8.2% at five years for those patients who underwent TEVAR.
The conclusions from the retrospective and above-mentioned RCTs have not been persuasive enough for the European Society of Vascular Surgery to render a higher recommendation than "TEVAR may be selectively considered" for those patients presenting with uncomplicated type B aortic dissections. This is furthermore echoed by a recent international survey regarding preferred treatment of uTBAD, in which 54.8% of respondents answered that they do not routinely use TEVAR, as opposed to 37.4% who prefer this strategy; moreover, 88.6% of respondents agreed that equipoise was present and that an RCT was warranted.
Research Objectives
Primary Objective
• To compare the overall survival at five years between subjects treated with SMT or SMT + subacute TEVAR.
Secondary Objectives
* To compare the risk of aortic-related mortality.
* To compare the risk of neurological injury, including stroke or paraplegia.
* To compare the proportion and indication of subjects who underwent an aortic intervention within 5 years due to development of an aortic complication.
* To compare the number of disease-related readmissions during follow-up.
* To compare, based on subgroup analyses, whether extent of TEVAR is associated with either improved survival or neurological injury.
* To compare the associated risk of reinterventions, including those subjects who were initially randomized to SMT and subsequently required an aortic intervention.
* To compare the associated changes in quality-of-life.
* To compare the 10-year overall survival and aortic-related mortality.
* To compare the costs.
Endpoint Definitions
Primary endpoint:
All-cause mortality.
Secondary endpoints:
Aortic-related mortality: Death as a result from aortic rupture or organ malperfusion, or death due to aortic intervention.
Aortic intervention: Any open surgical or endovascular intervention performed in any anatomical location, performed for the following indications, which are related to the aortic pathology: aneurysmal degeneration, visceral ischemia, lower extremity ischemia, rupture, or any of the criteria listed above under the definition of a complicated TBAD.
Neurological injury: These are divided into two categories: cerebrovascular accidents (CVA) and spinal cord ischemia (SCI). CVAs are defined according to the Society for Vascular Surgery reporting standards and classified as any central neurological complication, ischemic and hemorrhagic. For this project, the modified Rankin scale will be used for classifying stroke severity. Spinal cord ischemia is defined as either ischemic or hemorrhagic resulting in paraparesis or paraplegia. The modified Tarlov scoring scale will be used for the grading of any spinal cord injuries.
Reintervention: Any open or endovascular intervention after the original TEVAR procedure that was related to the dissection. These should be categorized as either planned reintervention, e.g., a staged procedure, or unplanned, which indicates a complication from the original procedure, a failure of the device, or progression of disease.
Quality of life: The quality of life will be assessed with the three following self-assessment forms:
1. The EuroQOL-5D-5L instrument from the EuroQol Group, comprised of five dimensions with five levels of scoring that can be combined into a five-digit number of description.
2. The Hospital and Anxiety Depression Score (HADS).
3. The 12-Item Short-Form (12-SF) Health Survey.
Economic evaluation: The economic evaluation will be performed from a payer/healthcare point of view, including resource use associated with healthcare, intervention and medication, whereas broader potential consequences for society, i.e., effects on productivity, will not be included. During the course of the trial, the accumulated costs will be measured per treatment arm from the participating hospital´s administrative/controlling/billing systems. As far as possible, the following resource use items will be included and captured as accumulated costs from the hospital's cost-per- subject system on all outpatient and inpatient visits:
* costs for healthcare staff
* subject -specific costs for primary and secondary endovascular and surgical procedures postoperative care unit costs
* costs of drugs during surgery and postoperative care
* costs of anaesthetic procedures and blood transfusions
* additional diagnostic procedures from the radiology and clinical physiology departments and from clinical chemistry.
The costs for healthcare staff will comprise the full wage costs, including costs for social security. Costs for each endovascular and surgical procedure will be retrieved individually, and, as far as possible, be based on the price per minute according to the hospital's cost-per- subject systems.
Changes in health status will be assessed in terms of quality-adjusted life-years (QALYs), which combine the time spent in a specific health state with the corresponding self-assessed health-related quality of life (HRQoL), as derived from the EuroQOL EQ-5D-5L questionnaire. Time is measured in years and the HRQoL is measured on an index scale ranging from 0 (equivalent to being dead) to 1 (best possible health state). The total number of QALYs will be calculated by multiplying the HRQoL index score (QALY weight) by the time spent in each health state. Group differences in total costs will be calculated and divided by the difference in QALYs in the interval from baseline until end of study, and the incremental cost-effectiveness ratio will be calculated as follows:
(CostTEVAR -CostSMT)/(QALYsTEVAR - QALYsSMT)=ΔCost/ΔQALY.
Rationale for objectives and endpoint selection
Despite evidence from retrospective and descriptive studies suggesting long-term benefits for early TEVAR intervention among uTBAD subjects, the underlying unanswered question is whether TEVAR confers a benefit of survival. The two previous RCTs, mentioned above, were underpowered to address this issue. Despite potential theoretical and procedural advantages of various composite endpoints, it was determined that a trial based on a clearly expressed question with a binary outcome will have the most clinical impact. Similarly, focus on the albeit interesting, but not essential, endpoint of aortic morphological changes and imaging findings, would complicate the pragmatic design of this trial.
Study Design
The trial is a randomized, open label, clinical trial with parallel assignment of subjects in multiple sites in Denmark, Sweden, Norway, Iceland, and Finland. Recruited subjects will be randomized to either SMT exclusively or TEVAR + SMT.
Conditions
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Aortic Dissection
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
The trial is a randomized, open label, clinical trial with parallel assignment of patients in multiple centres in Denmark, Sweden, Norway, Finland, Iceland, New Zealand, and the Netherlands. Recruited subjects will undergo stratified randomization based on the centre to either a control or intervention arm.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Data are collected and stored using the Research Electronic Data Capture (REDCap) software. Overall access is granted only to the Data and Safety Monitoring Committee and the Trial Steering Committee.
Study Groups
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Medical Therapy
Patients will be treated with standard medical therapy, i.e., antihypertensives, pulse-rate regulators, and pain medication.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Stent Therapy
Patients will be treated with both standard medical therapy, in addition to placement of a thoracic endovascular aortic repair stent graft.
Group Type
ACTIVE_COMPARATOR
TEVAR
Intervention Type
DEVICE
A TEVAR stent graft will be placed in the descending aorta in order to cover the primary entry of the dissection.
Interventions
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TEVAR
A TEVAR stent graft will be placed in the descending aorta in order to cover the primary entry of the dissection.
Intervention Type
DEVICE
Other Intervention Names
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Thoracic aortic endovascular repair stent graft
Eligibility Criteria
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Inclusion Criteria
All subjects, aged 18 or greater at the time of informed consent, admitted or referred to the participating vascular surgery site with an uTBAD of less than four weeks duration.
Exclusion Criteria
* Subjects with no signed informed consent.
* Subjects presenting with a complicated type B aortic dissection according to the above definition.
* Subjects previously treated in their descending aorta, either open surgery or TEVAR.
* Subjects with pre-existing thoracoabdominal aortic aneurysm.
* Subjects with other aortic pathology with an indication for intervention that requires TEVAR.
* Subjects with traumatic aortic dissections.
* Subjects with an established connective tissue disease at the time of randomization, including but not limited to Marfans and Loeys-Dietz syndrome.
* Subjects with a clinically estimated life expectancy \< 2 years.
* Subjects with dementia.
* Pregnant or nursing subjects.
* Subjects with current sepsis.
* Subjects currently participating in other clinical interventional trials.
* Subjects presenting with a complicated type B aortic dissection according to the above definition.
* Subjects previously treated in their descending aorta, either open surgery or TEVAR.
* Subjects with pre-existing thoracoabdominal aortic aneurysm.
* Subjects with other aortic pathology with an indication for intervention that requires TEVAR.
* Subjects with traumatic aortic dissections.
* Subjects with an established connective tissue disease at the time of randomization, including but not limited to Marfans and Loeys-Dietz syndrome.
* Subjects with a clinically estimated life expectancy \< 2 years.
* Subjects with dementia.
* Pregnant or nursing subjects.
* Subjects with current sepsis.
* Subjects currently participating in other clinical interventional trials.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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The Swedish Research Council
OTHER_GOV
Sponsor Role
collaborator
Swedish Heart Lung Foundation
OTHER
Sponsor Role
collaborator
University of Aarhus
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jacob W Budtz-Lilly, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Kevin Mani, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Uppsala University Hospital
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Site Status
RECRUITING
Aarhus University Hospital
Aarhus, , Denmark
Site Status
RECRUITING
Copenhagen University Hospital, Rigshospital
Copenhagen, , Denmark
Site Status
RECRUITING
Odense University Hospital
Odense, , Denmark
Site Status
RECRUITING
Helsinki University Hospital
Helsinki, , Finland
Site Status
RECRUITING
Kuopio University Hospital
Kuopio, , Finland
Site Status
NOT_YET_RECRUITING
Oulu University Hospital
Oulu, , Finland
Site Status
NOT_YET_RECRUITING
Tampere University Hospital
Tampere, , Finland
Site Status
RECRUITING
Turku University Hospital
Turku, , Finland
Site Status
RECRUITING
Landspitali University Hospital
Reykjavik, , Iceland
Site Status
RECRUITING
Amsterdam University Medical Center (AUMC)
Amsterdam, , Netherlands
Site Status
NOT_YET_RECRUITING
University Medical Center Groningen (UMCG)
Groningen, , Netherlands
Site Status
NOT_YET_RECRUITING
Leiden University Medical Center (LUMC)
Leiden, , Netherlands
Site Status
RECRUITING
Maastricht University Medical Center (MUMC)
Maastricht, , Netherlands
Site Status
NOT_YET_RECRUITING
Radboud University Medical Center (Radboudumc)
Nijmegen, , Netherlands
Site Status
NOT_YET_RECRUITING
Erasmus Medical Center (EMC)
Rotterdam, , Netherlands
Site Status
NOT_YET_RECRUITING
University Medical Center Utrecht (UMCU)
Utrecht, , Netherlands
Site Status
NOT_YET_RECRUITING
Haukeland University Hospital
Bergen, , Norway
Site Status
RECRUITING
Oslo University Hospital
Oslo, , Norway
Site Status
RECRUITING
University Hospital Nord
Tromsø, , Norway
Site Status
RECRUITING
St Olavs Hospital
Trondheim, , Norway
Site Status
RECRUITING
Sahlgrenska University Hospital
Gothenburg, , Sweden
Site Status
RECRUITING
Linköping University Hospital
Linköping, , Sweden
Site Status
RECRUITING
Skånes University Hospital
Malmo, , Sweden
Site Status
RECRUITING
Örebro University Hospital
Örebro, , Sweden
Site Status
ACTIVE_NOT_RECRUITING
Karolinska University Hospital
Stockholm, , Sweden
Site Status
RECRUITING
Sodersjukhuset
Stockholm, , Sweden
Site Status
RECRUITING
Uppsala University Hospital
Uppsala, , Sweden
Site Status
RECRUITING
Countries
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Denmark
Finland
Iceland
Netherlands
Norway
Sweden
Central Contacts
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Facility Contacts
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Mikko Jormalainen, MD PhD
Role: primary
References
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Rudolph C, Lindberg BR, Resch T, Mani K, Bjorkman P, Laxdal EH, Stovring H, Beck HM, Eriksson G, Budtz-Lilly J. Scandinavian trial of uncomplicated aortic dissection therapy: study protocol for a randomized controlled trial. Trials. 2023 Mar 23;24(1):217. doi: 10.1186/s13063-023-07255-7.
Reference Type
BACKGROUND
Related Links
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https://www.sundaytrial.dk
Homepage
Other Identifiers
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8240
Identifier Type: -
Identifier Source: org_study_id
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