Trial Outcomes & Findings for Evaluation of the Bifurcated Multilayer Flow Modulator for the Treatment of Abdominal Aortic Aneurysm (NCT NCT03024554)

Results Overview

Number of patients free from aortic aneurysm rupture at the 12-month timepoint

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

12 months

Results posted on

2026-08-10

Participant Flow

A total of 42 patients were consented and enrolled in the study at 7 investigational sites from 5 countries between 11 April 2014 and 30 June 2017. Treatment was attempted, and succesfully completed, in 41 patients, which constitute the analysed population. 40 patients were discharged from the hospital. During the 12-month follow-up period, 5 patients died and 5 were lost-to-follow-up, resulting in 30 patients being available at the 12-month time point.

Participant milestones

Participant milestones
Measure	Treatment Patients with aortic aneurysms involving the iliac arteries and morphology suitable for an endovascular procedure.
Overall Study NOT COMPLETED	12
Overall Study STARTED	42
Overall Study COMPLETED	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Patients with aortic aneurysms involving the iliac arteries and morphology suitable for an endovascular procedure.
Overall Study Lost to Follow-up	5
Overall Study Death	6
Overall Study Not implanted with study device	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=42 Participants Patients with aortic aneurysms involving the iliac arteries and morphology suitable for an endovascular procedure.
Age, Continuous	71 years STANDARD_DEVIATION 8 • n=42 Participants
Sex: Female, Male Female	4 Participants n=42 Participants
Sex: Female, Male Male	38 Participants n=42 Participants
Aneurysm Type Abdominal Aortic Aneurysm (AAA)	36 Participants n=42 Participants
Aneurysm Type Thoraco-abdominal Aortic Aneurysm (TAA)	1 Participants n=42 Participants
Aneurysm Type Unknown	5 Participants n=42 Participants
Aneurysm Morphology Fusiform	39 Participants n=42 Participants
Aneurysm Morphology Involving visceral branch	1 Participants n=42 Participants
Aneurysm Morphology Unknown	2 Participants n=42 Participants
Aneurysm location Infrarenal	22 Participants n=42 Participants
Aneurysm location Juxtarenal	14 Participants n=42 Participants
Aneurysm location Pararenal	2 Participants n=42 Participants
Aneurysm location Descending thoracic aortic aneurysm	1 Participants n=42 Participants
Aneurysm location Unknown	3 Participants n=42 Participants
Iliac artery involvement Both iliac	26 Participants n=42 Participants
Iliac artery involvement Left iliac only	3 Participants n=42 Participants
Iliac artery involvement Right iliac only	3 Participants n=42 Participants
Iliac artery involvement Unknown	10 Participants n=42 Participants
Maximum aneurysm diameter	60 mm STANDARD_DEVIATION 13 • n=39 Participants • Data from Core Laboratory unavailable for 3 subjects

PRIMARY outcome

Timeframe: 12 months

Population: Out of the 42 patients enrolled in the study, treatment was attempted in 41 patients (See Technical Success) which constitute the analysed population.

Number of patients free from aortic aneurysm rupture at the 12-month timepoint

Outcome measures

Outcome measures
Measure	Treatment n=41 Participants aortic aneurysm involving iliac arteries treatment with the Bifurcated Multilayer Flow Modulator (BMFM)
Number of Patients With Unruptured Aneurysm	41 Participants

PRIMARY outcome

Timeframe: At 30 days, 6 and 12 months

Population: Out of the 42 patients enrolled in the study, treatment was attempted in 41 patients (See Technical Success) which constitute the analysed population

Number of patients who had died as a consequence of their aortic aneurysm, at the 30-day, 6-month and 12-month timepoints

Outcome measures

Outcome measures
Measure	Treatment n=41 Participants aortic aneurysm involving iliac arteries treatment with the Bifurcated Multilayer Flow Modulator (BMFM)
Aneurysm-related Mortality At 30 days · At 30 days	0 participants
Aneurysm-related Mortality At 6 months · At 30 days	0 participants
Aneurysm-related Mortality At 12 months · At 30 days	0 participants

SECONDARY outcome

Timeframe: 12 months

Population: Out of the 42 patients enrolled in the study, treatment was attempted in 41 patients (See Technical Success) which constitute the analysed population The patency of the aortic side branches (visceral and renal arteries) covered by the multilayer stent will be assessed at the 12-month timepoints, compared to baseline

The patency of branches will be evaluated as follows: the number of branches patent will be evaluated on the total number of branches covered by the device (baseline data)

Outcome measures

Outcome measures
Measure	Treatment n=102 renal and visceral arteries aortic aneurysm involving iliac arteries treatment with the Bifurcated Multilayer Flow Modulator (BMFM)
Number of Branches and Collaterals Patent	98 renal and visceral arteries

SECONDARY outcome

Timeframe: 30 days, 6 months and 12 months

Population: Out of the 42 patients enrolled in the study, treatment was attempted in 41 patients (See Technical Success) which constitute the analysed population

Death from any cause

Outcome measures

Outcome measures
Measure	Treatment n=41 Participants aortic aneurysm involving iliac arteries treatment with the Bifurcated Multilayer Flow Modulator (BMFM)
All Cause Mortality 30-day mortality · 12 months	1 Participants
All Cause Mortality 6-month mortality · 12 months	2 Participants
All Cause Mortality 12-month mortality · 12 months	6 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Out of the 42 patients enrolled in the study, treatment was attempted in 41 patients (See Technical Success) which constitute the analysed population

Number of patients with Major Adverse Events (Major Adverse Events are defined as Serious Adverse Events)

Outcome measures

Outcome measures
Measure	Treatment n=41 Participants aortic aneurysm involving iliac arteries treatment with the Bifurcated Multilayer Flow Modulator (BMFM)
Number of Patients With Major Adverse Events	25 participants

SECONDARY outcome

Timeframe: The technical success was evaluated immediately at the end of procedure

Population: Device implantation was attempted in 41 out of the 42 enrolled patients

successful delivery and deployment of the BMFM® kit assessed immediately at the end of the procedure

Outcome measures

Outcome measures
Measure	Treatment n=41 Participants aortic aneurysm involving iliac arteries treatment with the Bifurcated Multilayer Flow Modulator (BMFM)
Technical Success Unsuccessful	0 Participants
Technical Success Successful	41 Participants

SECONDARY outcome

Timeframe: At procedure completion

Population: Out of the 42 patients enrolled in the study, treatment was attempted in 41 patients (See Technical Success) which constitute the analysed population. "Duration of anesthesia" was available for 32 of 41 patients.

The duration of the general anesthesia will be collected upon patient awakening

Outcome measures

Outcome measures
Measure	Treatment n=32 Participants aortic aneurysm involving iliac arteries treatment with the Bifurcated Multilayer Flow Modulator (BMFM)
Duration of Anesthesia	147.9 min Standard Deviation 52.7

SECONDARY outcome

Timeframe: During the Device Implantation Procedure

Population: Out of the 42 patients enrolled in the study, treatment was attempted in 41 patients (See Technical Success) which constitute the analysed population. Information for "Time of fluoroscopy" was available for 36 of 41 patients.

The duration of patient ionizing radiation exposure will be collected at the end of the procedure

Outcome measures

Outcome measures
Measure	Treatment n=36 Participants aortic aneurysm involving iliac arteries treatment with the Bifurcated Multilayer Flow Modulator (BMFM)
Time of Fluoroscopy Use During the Device Implantation Procedure	18.7 min Standard Deviation 14.9

SECONDARY outcome

Timeframe: During the Device Implantation Procedure

Population: Out of the 42 patients enrolled in the study, treatment was attempted in 41 patients (See Technical Success) which constitute the analysed population. Information on "Volume of constrast" was available from 38 patients.

Volume of contrast media used for imaging during the device implantation procedure

Outcome measures

Outcome measures
Measure	Treatment n=38 Participants aortic aneurysm involving iliac arteries treatment with the Bifurcated Multilayer Flow Modulator (BMFM)
Volume of Constrast Media Used During the Device Implantation Procedure	127.9 ml Standard Deviation 86.5

SECONDARY outcome

Timeframe: During the Device Implantation Procedure

Population: Out of the 42 patients enrolled in the study, treatment was attempted in 41 patients (See Technical Success) which constitute the analysed population. Information on "Estimated blood loss" was available for 37 of 41 patients.

Volume of blood lost by patient during the implantation procedure

Outcome measures

Outcome measures
Measure	Treatment n=37 Participants aortic aneurysm involving iliac arteries treatment with the Bifurcated Multilayer Flow Modulator (BMFM)
Estimated Blood Loss During Devie Implantation Procedure	136.2 ml Standard Deviation 100.3

SECONDARY outcome

Timeframe: At procedure completion

Population: Out of the 42 patients enrolled in the study, treatment was attempted in 41 patients (See Technical Success) which constitute the analysed population. Information on "Total device(s) deployment time" was available from 37 of 41 patients.

Total time required to position and deploy the device (from sheath-in to sheath-out)

Outcome measures

Outcome measures
Measure	Treatment n=37 Participants aortic aneurysm involving iliac arteries treatment with the Bifurcated Multilayer Flow Modulator (BMFM)
Total Device(s) Deployment Time	13.1 min Standard Deviation 11.1

SECONDARY outcome

Timeframe: At hospital discharge

Population: Out of the 42 patients enrolled in the study, treatment was attempted in 41 patients (See Technical Success) which constitute the analysed population. Information on "Hospital stay duration" was available from 34 of 41 patients.

Patient hospital stay duration, from admission to discharge post-procedure

Outcome measures

Outcome measures
Measure	Treatment n=34 Participants aortic aneurysm involving iliac arteries treatment with the Bifurcated Multilayer Flow Modulator (BMFM)
Hospital Stay Duration	5 days Standard Deviation 4

Adverse Events

Treatment

Serious events: 25 serious events

Other events: 2 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=41 participants at risk The analysed population consists of the 41 patients in whom the device treatment was attempted (out of the 42 enrolled patients with aortic aneurysms involving iliac arteries and morphology suitable for endovascular procedure).
Vascular disorders Aneurysm expansion	9.8% 4/41 • From enrollment up to 12 months included
Vascular disorders Thrombosis/Thrombus	24.4% 10/41 • From enrollment up to 12 months included
Cardiac disorders Bradycardia	2.4% 1/41 • From enrollment up to 12 months included
General disorders Obstruction/Occlusion	4.9% 2/41 • From enrollment up to 12 months included
General disorders Stenosis	17.1% 7/41 • From enrollment up to 12 months included
General disorders Insufficient Information (Death of unknwon cause)	4.9% 2/41 • From enrollment up to 12 months included
Renal and urinary disorders A condition that is characterized by the inability of the kidneys to adequately filter	2.4% 1/41 • From enrollment up to 12 months included
Vascular disorders Spontaneous or induced tear within the wall of a blood vessel.	2.4% 1/41 • From enrollment up to 12 months included
Vascular disorders Aortic dissection	2.4% 1/41 • From enrollment up to 12 months included
Cardiac disorders Coronary obstruction/occlusion	2.4% 1/41 • From enrollment up to 12 months included
Cardiac disorders The sudden cessation of productive cardiac activity in an individual who becomes unresponsive	2.4% 1/41 • From enrollment up to 12 months included
Respiratory, thoracic and mediastinal disorders An uncomfortable sensation of difficulty breathing	2.4% 1/41 • From enrollment up to 12 months included
Respiratory, thoracic and mediastinal disorders An infectious disease affecting the respiratory tract	2.4% 1/41 • From enrollment up to 12 months included
Gastrointestinal disorders Bleeding originating from any part of the gastrointestinal tract.	2.4% 1/41 • From enrollment up to 12 months included
Infections and infestations Any disease caused by a virus	2.4% 1/41 • From enrollment up to 12 months included
Infections and infestations A state of acute circulatory failure resulting from organ injury or damage	2.4% 1/41 • From enrollment up to 12 months included

Other adverse events

Other adverse events
Measure	Treatment n=41 participants at risk The analysed population consists of the 41 patients in whom the device treatment was attempted (out of the 42 enrolled patients with aortic aneurysms involving iliac arteries and morphology suitable for endovascular procedure).
Vascular disorders The formation of a blood clot in the lumen of a vessel or heart chamber.	4.9% 2/41 • From enrollment up to 12 months included

Additional Information

Pierre DOUETTE

Cardiatis S.A.

Phone: +32 81 719 941

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place