Aortic AneurysmEPICATANCT03718312
Evaluation of the Effectiveness of Ischemic Pre-conditioning on the Morbidity and Mortality of Open Surgery of Thoracoabdominal Aortic Aneurysms.
A study testing clamping with pre-conditioning (PCl) in people with Aortic Aneurysm and Surgery, run by University Hospital, Rouen at 1 site in France.
Trial summary
Patients having a planned open surgery of thoracoabdominal aortic aneurysms and enrolled in the study will be randomized the day of the surgery in 2 groups: Arm 1 : Patients with aortic clamping with pre-conditioning Arm 2 : Patients with aortic clamping without pre-conditioning Patients will be then followed, during… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aortic Aneurysm, Surgery
- What is being tested?
- clamping with pre-conditioning (PCl)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jul 2019to 11 Jul 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient > 18 and <85 years old
- Patient having a planned surgery for a thoracoabdominal aortic aneurysm by direct approach,
- Patient with aortic aneurysm requiring supra-visceral aortic clamping and visceral artery reconstruction,
- Aortic aneurysmal patient with or without distal femoral circulatory assistance,
- Patient with aortic aneurysm of atheromatous or dissecting etiology,
- Woman of childbearing potential with effective contraception (estrogen-progestin or intrauterine device or tubal ligation), postmenopausal woman (≥ 12 months of amenorrhea not induced by therapy)
- Patient who read and understood the newsletter and signed the consent form
- Patient affiliated with a social security scheme
Who cannot join
- Patient with aortic aneurysms requiring supra-visceral aortic clamping but not requiring visceral artery reconstruction (supra-visceral aortic clamping for renal aortic juxtaposition aorta),
- Patient with thoraco abdominal aortic aneurysms requiring a circulatory arrest (aortic aneurysms affecting the descending thoracic aorta or the aortic arch)
- Patient requiring emergency aortic surgery
- Patient under treatment known as interfering with PCI (Nicorandil or oral antidiabetic agents),
- Pregnant or lactating woman (negative result of baseline blood test)
- Participation in another interventional study within 28 days before randomization or during this study
- Person deprived of liberty by an administrative or judicial decision or person subject to a legal measure for the protection of adults,
- Patient under the protection of justice, patient under guardianship or curatorship.
Trial locations and contacts
1 site in 1 country.
About this study
Patients having a planned open surgery of thoracoabdominal aortic aneurysms and enrolled in the study will be randomized the day of the surgery in 2 groups:
- Arm 1 : Patients with aortic clamping with pre-conditioning
- Arm 2 : Patients with aortic clamping without pre-conditioning Patients will be then followed, during 60 days after surgery.
- Conditions
- Aortic Aneurysm, Surgery
- Being tested
- clamping with pre-conditioning (PCl)
- Keywords
- Clamping, pre-conditioning
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clamping with pre-conditioning (PCl)Procedure or surgery
PCI procedure: clamping of the supracellular thoracic aorta for 5 minutes followed by a 5-minutes de-clamping period.
PCI procedure is repeated twice.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients with aortic clamping withpre-conditioning Receives: Procedure: clamping with pre-conditioning (PCl) |
| Arm 2 | No intervention | Patients with aortic clamping without pre-conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of a pulmonary complication
Need for prolonged invasive ventilation
Measured: Before the 48 hours after the beginning surgery
occurrence of a kidney complication
According to RIFLE criteria
Measured: During the 8 days after surgery
occurrence of a pulmonary complication
Occurrence of a moderate or severe acute respiratory distress syndrome (Berlin definition)
Measured: During the 8 days after surgery
occurrence of a pulmonary complication
Need for a new ventilation (invasive or not)
Measured: During the 48 hours after initial extubation
Secondary outcomes (5)
Pulmonary Morbidity
Need of a new ventilation (invasive or not)
Measured: During the 21 days after surgery
Kidney Morbidity
According to RIFLE criteria
Measured: During the 21 days after surgery
Cardiac Morbidity
Value of troponin
Measured: During the 48 hours after surgery
cell and tissue damage
Value of D Lactate
Measured: During the 8 days after surgery
Death
Measured: During 60 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start29 Jul 2019
- Primary completion11 Jul 2023
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718312
- Sponsor's protocol ID
- 2017/388/HP
- Acronym
- EPICATA
- Status last verified
- Sep 2023
- First submitted
- 23 Oct 2018
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.
PubMed 36645250Palmier M, Bubenheim M, Chiche L, Chaufour X, Koskas F, Fadel E, Magnan PE, Ducasse E, Chakfe N, Steinmetz E, Dusseaux MM, Ricco JB, Plissonnier D. Protocol of supra-visceral aortic ischemic preconditioning for open surgical repair of thoracoabdominal aortic aneurysm : The EPICATA study (Evaluation of the Efficacy of Ischemic PreConditioning on morbidity and mortality in open ThoracoAbdominal Aortic surgery). BMC Surg. 2020 Aug 27;20(1):193. doi: 10.1186/s12893-020-00851-3.
PubMed 32854681
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Ischemic Pre-conditioning on the Morbidity and Mortality of Open Surgery of Thoracoabdominal Aortic Aneurysms.
- ClinicalTrials.gov ID
- NCT03718312
- Acronym / sponsor ID
- EPICATA / 2017/388/HP
- Conditions
- Aortic Aneurysm, Surgery
- Keywords
- Clamping, pre-conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 11 Jul 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 24 Oct 2018 (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.
Patients having a planned open surgery of thoracoabdominal aortic aneurysms and enrolled in the study will be randomized the day of the surgery in 2 groups:
- Arm 1 : Patients with aortic clamping with pre-conditioning
- Arm 2 : Patients with aortic clamping without pre-conditioning Patients will be then followed, during 60 days after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: clamping with pre-conditioning (PCl)Patients with aortic clamping withpre-conditioning |
| Arm 2 | No intervention | –Patients with aortic clamping without pre-conditioning |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient > 18 and <85 years old
- Patient having a planned surgery for a thoracoabdominal aortic aneurysm by direct approach,
- Patient with aortic aneurysm requiring supra-visceral aortic clamping and visceral artery reconstruction,
- Aortic aneurysmal patient with or without distal femoral circulatory assistance,
- Patient with aortic aneurysm of atheromatous or dissecting etiology,
Key exclusion criteria (8 listed)
- Patient with aortic aneurysms requiring supra-visceral aortic clamping but not requiring visceral artery reconstruction (supra-visceral aortic clamping for renal aortic juxtaposition aorta),
- Patient with thoraco abdominal aortic aneurysms requiring a circulatory arrest (aortic aneurysms affecting the descending thoracic aorta or the aortic arch)
- Patient requiring emergency aortic surgery
- Patient under treatment known as interfering with PCI (Nicorandil or oral antidiabetic agents),
- Pregnant or lactating woman (negative result of baseline blood test)
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 |
|---|---|---|
| clamping with pre-conditioning (PCl)PCI procedure: clamping of the supracellular thoracic aorta for 5 minutes followed by a 5-minutes de-clamping period. PCI procedure is repeated twice. | Procedure or surgery | Arm 1 |
Primary outcome
occurrence of a pulmonary complication
Time frame: Before the 48 hours after the beginning surgery
Need for prolonged invasive ventilation
occurrence of a kidney complication
Time frame: During the 8 days after surgery
According to RIFLE criteria
occurrence of a pulmonary complication
Time frame: During the 8 days after surgery
Occurrence of a moderate or severe acute respiratory distress syndrome (Berlin definition)
occurrence of a pulmonary complication
Time frame: During the 48 hours after initial extubation
Need for a new ventilation (invasive or not)
5 secondary outcomes
Pulmonary Morbidity
Time frame: During the 21 days after surgery
Kidney Morbidity
Time frame: During the 21 days after surgery
Cardiac Morbidity
Time frame: During the 48 hours after surgery
cell and tissue damage
Time frame: During the 8 days after surgery
Death
Time frame: During 60 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Derived from this study: PubMed 36645250Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.
- Derived from this study: PubMed 32854681Palmier M, Bubenheim M, Chiche L, Chaufour X, Koskas F, Fadel E, Magnan PE, Ducasse E, Chakfe N, Steinmetz E, Dusseaux MM, Ricco JB, Plissonnier D. Protocol of supra-visceral aortic ischemic preconditioning for open surgical repair of thoracoabdominal aortic aneurysm : The EPICATA study (Evaluation of the Efficacy of Ischemic PreConditioning on morbidity and mortality in open ThoracoAbdominal Aortic surgery). BMC Surg. 2020 Aug 27;20(1):193. doi: 10.1186/s12893-020-00851-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clamping with pre-conditioning (PCl) in people with Aortic Aneurysm and Surgery, run by University Hospital, Rouen at 1 site in France.
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 8 inclusion and 8 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: finished, as of the sponsor's last update on 15 Jun 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of a pulmonary complication (time frame: Before the 48 hours after the beginning surgery). The study lists 4 primary outcomes in all. 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 NCT03718312, which also lists 2 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 15 Jun 2026.