NCT03038438

ABRE Clinical Study of the Abre Venous Self-expanding Stent System

Completed NA Results posted Last updated 8 November 2022

What this trial tests

NA trial testing Abre venous self-expanding stent system in Iliofemoral Venous Obstruction in 260 participants. Completed in 28 January 2022.

Timeline

13 December 2017

Primary endpoint
14 January 2020

28 January 2022

Quick facts

Lead sponsor	Medtronic Endovascular
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	260
Start date	13 December 2017
Primary completion	14 January 2020
Estimated completion	28 January 2022
Sites	24 locations across France, Italy, Ireland, United Kingdom, Germany, United States

Drugs / interventions tested

• Abre venous self-expanding stent system

Conditions studied

• Iliofemoral Venous Obstruction — all drugs for Iliofemoral Venous Obstruction →

Sponsor

Medtronic Endovascular — full company profile →

Who can join

Adults 18 to 80, any sex, with Iliofemoral Venous Obstruction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Primary Patency Primary · 12 Months

Freedom from occlusion of the stented segment; Freedom from restenosis \>=50%; and Freedom from clinically-driven target lesion revascularization

Group	Value	95% CI
ABRE	162

Composite Major Adverse Events Primary · 30 Days

The components of the Major Adverse Events include: All-cause death occurring post-procedure, clinically-significant pulmonary embolism, major bleeding complication, stent thrombosis, and stent migration

Group	Value	95% CI
ABRE	4

Device Success Secondary · Index Procedure

Successful delivery and deployment of the stent and removal of the delivery system during the index procedure. Stent based outcome measure.

Group	Value	95% CI
ABRE	302

Lesion Success Obtained at Index Procedure Secondary · Index Procedure

Venographic evidence of \<50% residual stenosis of the stented segment of the target lesion after post-dilation.

Group	Value	95% CI
ABRE	200

Index Procedure Success Secondary · 30 days

Lesion success without procedure-related MAEs prior to hospital discharge

Group	Value	95% CI
ABRE	198

Primary Patency Secondary · 24 Months, 36 Months

Primary Patency: Defined as meeting all of the following criteria: * Freedom from occlusion of the stented segment of the target lesion; * Freedom from restenosis ≥50% of the stented segment of the target lesion; * Freedom from clinically driven target lesion revascularization.

24 Months

Group	Value	95% CI
ABRE	86.2

36 Months

Group	Value	95% CI
ABRE	81.6

Primary Assisted Patency Secondary · 12 Months, 24 Months, 36 Months

Uninterrupted patency of the stented segment of the target lesion with a secondary intervention, also known as an adjunctive treatment (e.g. balloon venoplasty, subsequent stenting, etc.)

12 Months

Group	Value	95% CI
ABRE	97.0

24 Months

Group	Value	95% CI
ABRE	90.2

36 Months

Group	Value	95% CI
ABRE	84.8

Secondary Patency Secondary · 12 Months, 24 Months, 36 Months

Secondary patency is defined as patency of the stented segment of the target lesion after subsequent intervention for an occlusion.

12 Month

Group	Value	95% CI
ABRE	99.0

24 Months

Group	Value	95% CI
ABRE	91.8

36 Months

Group	Value	95% CI
ABRE	86.3

Stent Fracture Secondary · 30 Days, 12 Months, 24 Months, 36 Months

X-ray for the 30-day visit was only required on the first 30 subjects. Stent Fracture within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1080, respectively.

30 Day

Group	Value	95% CI
ABRE	0

12 Months

Group	Value	95% CI
ABRE	0

24 Months

Group	Value	95% CI
ABRE	0

36 Months

Group	Value	95% CI
ABRE	0

Target Lesion Revascularization Secondary · 30 days, 6 months, 12 months, 24 months, 36 months

Percentage of subjects with target lesion revascularization through 30 days, 180 days, 360 days, 720, and 1080 days.

30 Days

Group	Value	95% CI
ABRE	3.0

6 Months

Group	Value	95% CI
ABRE	7.5

12 Months

Group	Value	95% CI
ABRE	11.1

24 Months

Group	Value	95% CI
ABRE	14.7

36 Months

Group	Value	95% CI
ABRE	16.3

Delayed Stent Migration Secondary · 12 Months, 24 Months, 36 Months

Delayed Stent Migration within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1140, respectively.

12 Months

Group	Value	95% CI
ABRE	0

24 Months

Group	Value	95% CI
ABRE	0

36 Months

Group	Value	95% CI
ABRE	0

Major Adverse Events Secondary · 6 Months, 12 Months, 24 Months, 36 Months

Safety endpoints (MAE, TLR, and Major Bleeding) included subjects with an event or without an event but follow-up days have reached 150 days for 6-month, 330 days for 12-month, 690 days for 24-month, and 1050 days for 36-month visit.

Within 6 Months

Group	Value	95% CI
ABRE	4.5

Within 12 Months

Group	Value	95% CI
ABRE	6.0

Within 24 Months

Group	Value	95% CI
ABRE	8.6

Within 36 Months

Group	Value	95% CI
ABRE	10.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Through 1080 Days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ABRE

Serious: 86/200 (43%)

Deaths: 3/200

Serious adverse events (91 terms)

Reaction	System	ABRE
VASCULAR STENT THROMBOSIS	General disorders	—
VASCULAR STENT STENOSIS	General disorders	—
PNEUMONIA	Infections and infestations	—
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	—
DEEP VEIN THROMBOSIS	Vascular disorders	—
ATRIAL FIBRILLATION	Cardiac disorders	—
SKIN ULCER	Skin and subcutaneous tissue disorders	—
VARICOSE VEIN	Vascular disorders	—
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	—
COVID-19	Infections and infestations	—
BACK PAIN	Musculoskeletal and connective tissue disorders	—
ACUTE KIDNEY INJURY	Renal and urinary disorders	—
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	—
ANAEMIA	Blood and lymphatic system disorders	—
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	—
ABDOMINAL HERNIA	Gastrointestinal disorders	—
MENISCUS INJURY	Injury, poisoning and procedural complications	—
VASCULAR ACCESS SITE HAEMATOMA	Injury, poisoning and procedural complications	—
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	—
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	—
HYPOTENSION	Vascular disorders	—
LYMPHOEDEMA	Vascular disorders	—
ACUTE LEFT VENTRICULAR FAILURE	Cardiac disorders	—
BRADYCARDIA	Cardiac disorders	—
CARDIAC FAILURE	Cardiac disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	ABRE
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: VASCULAR STENT THROMBOSIS, VASCULAR STENT STENOSIS, PNEUMONIA, OSTEOARTHRITIS, DEEP VEIN THROMBOSIS, ATRIAL FIBRILLATION, SKIN ULCER, VARICOSE VEIN.

Data from ClinicalTrials.gov NCT03038438 adverse events section.

Sponsor's own description

Evaluate the safety and effectiveness of the Abre venous self-expanding stent system for treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pivotal Study Evaluating the Safety and Effectiveness of the Abre Venous Self-Expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction.
   Murphy E, Gibson K, Sapoval M, Dexter DJ, et al · · 2022 · cited 60× · PMID 35105153 · DOI 10.1161/circinterventions.121.010960