Contrast Strategy In Fenestrated EndoVascular Aneurysm Repair Randomized Control Trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Skane

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2025-12-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To explore if a strategy aimed at reducing the exposure to iodine contrast medium, achieved by preferentially using carbon dioxide (CO2) to visualize arteries during FEVAR when possible, reduces the postoperative incidence of AKI following FEVAR of abdominal aortic aneurysms compared to the standard of care.

Secondary objectives 12

1. Percentage of patients developing AKI stage 1 and above according to KDIGO
2. The rate of technical success of the repair
3. The image quality
4. The radiation exposure
5. The detection of endoleaks
6. The incidence of adverse events
7. Quality of life before and after the procedure up to 3 years
8. Recovery at day 2, and cognitive function at 1 month
9. Clinical success of the repair during the follow-up
10. Incidence of with chronic kidney disease, up to 3 years
11. Need for reinterventions to keep the clinical success
12. Survival up to 3 years

Conditions and MedDRA coding

Abdominal aortic aneurysm

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. The subject has given their written consent to participate in the trial.
2. Planned elective FEVAR of juxtarenal or pararenal aneurysm aortic aneurysm within six months, using a customized fenestrated endograft based on stainless steel stents and polyester graft.
3. ≥ 18 years old
4. For female participants in fertile age a negative pregnancy test is required followed by highly effective birth control methods after inclusion and until the termination of the trial.

Exclusion criteria 12

1. Severe COPD (Chronic Obstructive Pulmonary Disease)
2. Known atrium‐ or ventricular septal defect with right‐left‐shunt
3. Thyrotoxicosis
4. Severe renal arteries atherosclerosis (≥ 50%) in any of the renal arteries
5. Shaggy aorta
6. Distal extension of the disease requiring iliac branch devices or hypogastric embolization/coverage
7. Contrast agent allergy even if premedication is used
8. FEVAR done with anaesthesia other than general anaesthesia
9. Inflammatory or infective aneurysm
10. Current participation in other clinical interventional trials (registers and non-interventional studies are allowed)
11. Pregnancy or breast feeding
12. Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of participation in the trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of patients with AKI, defined as RIFLE stage R (Risk) and above during the early postoperative period according to the RIFLE classification (Risk, Injury, Failure, Loss of kidney function, End-stage kidney disease) suggested in the reporting standards for complex aortic repair.

Secondary endpoints 11

1. Kidney function; Incidence of patients developing AKI stage 1 and above, according to KDIGO classification, based on Serum creatinine assessment and urinary output
2. Success of surgery; Number and percent of patients fulfilling the definitions of the immediate technical and primary and secondary clinical successes (calculated with the life-tables), based on clinical and imaging endpoints at the FEVAR and CT during follow-up at 1 months and yearly up to 3 years
3. Intraoperative imaging assessment: - Image quality assessed by a 5-point Likert scale; -Incidence of detected endoleaks and their type; - Radiation exposure and Absorbed Dose
4. Percentage of patients experiencing adverse events until discharge and adverse events of special interest up to 3 years after FEVAR (number, type and severity)
5. The quality of life before and after the procedure measured by the EQ-5D-5l instrument preoperatively, at discharge, 1 month, and 1, 2, and 3 years
6. Swedish Quality of Recovery Scale (SwQoR) at day 2 postoperatively; and MoCa before the procedure and at 1 month
7. Survival up to 3 years (percent of surviving patients)
8. Percentage of patients whose cause of death is related to aortic repair and renal insufficiency, up to 3 years after FEVAR
9. Percentage of patients with CKD stage 2 and above within 3 years, according to the National Kidney Foundation Kidney Disease Outcomes Quality Initiative classification, based on the assessment of eGFR
10. Percentage of patients with worsening of CKD stage within 3 years according to the National Kidney Foundation Kidney Disease Outcomes Quality Initiative classification, based on the assessment of eGFR
11. Reintervention

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Skane

Sponsor organisation

Region Skane

Address

Dockplatsen 26, Malmo S:t Petri Malmo S:t Petri

City

Malmo

Postcode

211 74

Country

Sweden

Scientific contact point

Organisation

Region Skane

Contact name

Vascular Center, Skåne University Hospital Malmö

Public contact point

Organisation

Region Skane

Contact name

Vascular Center, Skåne University Hospital Malmö

Third parties 2

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications