Clinical trial NCT03449875: Global Post-market Registry for the Treovance Stent-graft.
Official title: A Post-Market Surveillance Clinical Registry of the TREOVANCE® Stent-Graft for Patients With Infrarenal Abdominal Aortic Aneurysms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: Bolton Medical
Sponsor class: INDUSTRY
First posted: 2018-02-28
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects diagnosed with infrarenal aortic aneurysms requiring endovascular repair.

Brief summary: Patients with abdominal aortic aneurysms (AAA) suitable for endovascular aortic repair (EVAR) with Treovance were eligible to participate. Main inclusion criteria were: age 18-85 years; infrarenal AAA without significant infrarenal or distal iliac landing neck calcification or thrombus formation; infrarenal or distal iliac landing neck size requirements specified in the instructions for use. Main exclusion criteria: dissection/ruptured aneurysm or prior AAA endovascular or surgical repair. The primary endpoints were standard EVAR criteria.

Detailed description: The goal of the registry was to collect clinical data of TREOVANCE® device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology is treated with an acceptable technical success rate, an acceptable complication rate and that the device performs as expected.

The following endovascular measures/parameters were assessed for preliminary performance at the follow-up intervals: delivery/deployment, stent-graft migration, stent-graft patency, stent-graft integrity, endoleak, aneurysm sac size changes, limb ischemia, and vascular access complications.

This registry was a prospective, multi-center, post-market non-randomized study. The goal was to gather safety and performance data on the device. Subjects diagnosed with infrarenal aortic aneurysms enrolled into the registry were treated with the TREOVANCE® Stent-Graft with Navitel® Delivery System. Pre-procedure baseline data was gathered as well as post-procedure assessments prior to hospital discharge and 1, 6, and 12 months post-implantation.

Eligibility criteria: Inclusion Criteria:

* Subject must be between the ages of 18 and 85.
* Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement, by CT with contrast performed within 3 months of planned implant procedure.
* Subject must have an infrarenal AAA that i. is \> 4.5 cm in diameter for females and \> 5 cm for males. ii. has increased in diameter by 0.5 cm in the last 6 months
* Subject must have i. infrarenal landing neck length of 10 mm or greater and an angle of less than 60 degrees relative to the long axis of the aneurysm (centerline at lowest renal to centerline at bifurcation) and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an inside diameter of 17 mm - 32 mm, or ii. infrarenal landing neck length of 15 mm or greater and an angle of between 60 and 75 degrees relative to the long axis of the aneurysm and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an inside diameter of 16 mm-30 mm
* Subject's infrarenal landing neck must i. have no significant calcification or thrombus formation, and ii. meet the vessel size requirements specified in the instructions for use (IFU) for the corresponding devices
* Subject must have lowest renal artery at least 9 cm from the aortic bifurcation
* Subject must have a distal iliac landing neck with i. an inside diameter of 7 mm - 13 mm and a length of at least 10 mm, or ii. an inside diameter of \>13 mm - 20 mm and a length of at least 15 mm
* Subject's distal iliac landing neck must i. have no significant calcification or thrombus formation, and ii. meet the vessel size requirements specified for the corresponding devices in the IFU
* Subject must have a total treatment length of at least 13 cm
* Subject must be willing and able to comply with 1-month, 6-month, and 12-month follow-up visits.
* Subject must have adequate vascular access (e.g., patent iliac or femoral arteries) for introduction of the Navitel® Delivery System which is 18F (6 mm) or 19F (6.3 mm) outer diameter based on size of device used. Alternatively, subject's anatomy is suitable for creation of an iliac conduit.
* Subject or Legally Authorized Representative (LAR) must agree to sign hospital issued Informed Consent Form

Exclusion Criteria:

* Subject is pregnant or lactating
* Subject has a dissection or a ruptured aneurysm (as determined by treating physician).
* Subject has a patent inferior mesenteric artery that cannot be sacrificed and an occluded or stenotic celiac and/or superior mesenteric artery
* Implant procedure as planned does not allow for at least one patent hypogastric artery left intact, unless both are occluded on pre-op imaging
* Subject has a lesion that cannot be crossed by a guide wire
* Proximal neck cannot increase by more than 20% over 15 mm; i.e., no conical necks
* Subject has severe untreated coronary artery disease and/or unstable angina, significant areas of myocardium at risk (based on coronary angiogram or radionuclide scans), left ventricular ejection fraction \< 20%, or recent diagnosis of CHF
* Subject has had a stroke or MI within 6 months of the planned treatment date
* Subject has chronic obstructive pulmonary disease requiring routine need for oxygen therapy outside the hospital setting (e.g., daily or nightly home use)
* Subject has an active systemic infection or is suspected of having an active systemic infection (e.g., AIDS/HIV, sepsis)
* Subject is morbidly obese (more than 100% over the ideal body weight or as defined by institutional standards) or has other clinical conditions that severely compromise or impair x-ray visualization of the aorta
* Subject has significant or circumferential mural thrombus in the proximal aortic neck
* Subject has a blood coagulation disorder or bleeding diathesis the treatment for which cannot be suspended pre- and post-repair
* Subject is in acute or chronic renal failure (creatinine \> 2.5 mg/dL)
* Subject has less than two-year life expectancy as evidenced by factors prohibiting major medical intervention (e.g., presence of malignancy, severe cardiopulmonary disease, etc.)
* Subject is participating in another research study, has received investigational study drug within 30 days of planned procedure, or has received an investigational device within one year of planned procedure.
* Subject is confronted with other medical, social or psychological issues that the investigator believes may interfere with study treatment or follow-up. These reasons must be documented. An example may include adherence to a theological or personal doctrine with aversion or opposition to blood transfusion.
* Subject has had a prior AAA repair (endovascular or surgical)
* Subject has an untreatable allergy or sensitivity to contrast media, nitinol/nickel, or polyester
* Subject has undergone other major surgical or medical intervention within 45 days of the planned procedure or is planning to undergo other major surgical or medical intervention within 45 days post implantation (e.g., CABG, organ transplantation, renal stenting, etc.)

Primary outcomes:
measure: Number of subjects reporting Major Adverse Events
timeFrame: Through 12 months
Secondary outcomes:
measure: Rate of Device Delivery/Deployment Success
timeFrame: Procedure / Study Day 0
measure: Rate of Stent-Graft Migration greater than 10mm
timeFrame: 6 months and 12 months
measure: Rate of Stent-Graft Patency
timeFrame: 1 month, 6 months and 12 months
measure: Rate of Stent-Graft Integrity
timeFrame: 1 month, 6 months and 12 months
measure: Rate of Endoleaks
timeFrame: 1 month, 6 months and 12 months
measure: Rate of Aneurysm Sac Size Changes
timeFrame: 6 months and 12 months
measure: Rate of Limb Ischemia
timeFrame: 1 month, 6 months and 12 months
measure: Rate of Vascular Access Complications
timeFrame: 1 month, 6 months and 12 months
measure: Rate of unintentional covering of renal arteries and / or hypogastric arteries
timeFrame: Procedure / Study Day 0
Other outcomes:
measure: Summary results of procedural data and outcomes
timeFrame: 1 month, 6 months and 12 months
Locations:
city: Santiago
country: Chile
facility: Hospital Barros Luco Trudeau
city: Santiago
country: Chile
facility: Hospital de la Dirección de Previsión de Carabineros de Chile
city: Copenhagen
country: Denmark
facility: Rigshospitalet, National Hospital and University of Copenhagen
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Lingen
country: Germany
facility: Bonifatius Hospital
city: Mannheim
country: Germany
facility: Theresienkrankenhaus und St. Hedwig-Klinik
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Athens
country: Greece
facility: Evaggelismos General Hospital
city: Thessaloníki
country: Greece
facility: Georgios Gennimatas Thessaloniki General Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, University of Hong Kong
city: Budapest
country: Hungary
facility: Semmelweis Medical University Budapest
city: Cork
country: Ireland
facility: Cork University Hospital
city: Acerra
country: Italy
facility: Casa Di Cura Villa Dei Fiori
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Almelo
country: Netherlands
facility: ZiekenhuisGroep Twente
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1
city: A Coruña
country: Spain
facility: Hospital HM Modelo
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Solna
country: Sweden
facility: Karolinska University Hospital
city: Lampang
country: Thailand
facility: Lampang Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital, Cambridge University Hospitals
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary, Central Manchester University Hospitals
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital, Oxford University Hospitals
city: Caracas
country: Venezuela
facility: Instituto Urológico San Román
city: Ho Chi Minh City
country: Vietnam
facility: Cho Ray Hospital
Study officials:
affiliation: Department of Medicine, Surgery and Neuroscience, University of Siena Viale Bracci 1, 53100 Siena, Italy
name: Carlo Setacci, MD, PhD
role: STUDY_CHAIR
References:
citation: Murray D, Szeberin Z, Benevento D, Abdallah F, Palasciano G, Lescan M, Uberoi R, Setacci C. A comparison of clinical outcomes of abdominal aortic aneurysm patients with favorable and hostile neck angulation treated by endovascular repair with the Treovance stent graft. J Vasc Surg. 2020 Jun;71(6):1881-1889. doi: 10.1016/j.jvs.2019.07.096. Epub 2019 Nov 2.
citation: Uberoi R, Setacci C, Lescan M, Lorido A, Murray D, Szeberin Z, Zubilewicz T, Riambau V, Chartrungsan A, Tessarek J; RATIONALE Investigators. Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry. J Endovasc Ther. 2018 Dec;25(6):726-734. doi: 10.1177/1526602818803939. Epub 2018 Oct 3.