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CompletedNCT03449875RATIONALEUpdated Jun 26, 2020

Global Post-market Registry for the Treovance Stent-graft.

An observational study in Abdominal Aortic Aneurysm, sponsored by Bolton Medical. Completed at 32 sites in 17 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-06-26.

Sponsored by Bolton Medical · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
202
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Abdominal Aortic Aneurysm
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subjects diagnosed with infrarenal aortic aneurysms requiring endovascular repair.

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

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.)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
202 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Interventions

  • DeviceTREOVANCE® Stent-Graft with Navitel® Delivery System

    Endovascular repair of abdominal aortic aneurysms.

05

What researchers measure

Primary outcomes

  1. Number of subjects reporting Major Adverse Events

    Primary safety outcome will be assessed by measurement of mortality and major morbidity rates through reporting of the following events: * Death * Stroke * Myocardial Infarction * Renal Failure requiring renal replacement therapy * Respiratory Failure, defined as ventilator-dependent * Paraparesis / Paraplegia (excludes paraparesis) * Bowel ischemia * Treated aneurysm rupture

    Time frame: Through 12 months

Secondary outcomes

  1. Rate of Device Delivery/Deployment Success

    Device effectiveness will be measured through the rate of successful delivery and deployment during the index procedure

    Time frame: Procedure / Study Day 0

  2. Rate of Stent-Graft Migration greater than 10mm

    Device effectiveness will be measured by the rate of Stent-Graft Migration greater than 10mm as compared to the first post procedure imaging

    Time frame: 6 months and 12 months

  3. Rate of Stent-Graft Patency

    Device effectiveness will be measured by the rate of Stent-Graft Patency observed

    Time frame: 1 month, 6 months and 12 months

  4. Rate of Stent-Graft Integrity

    Device effectiveness will be measured by the rate of Stent-Graft Integrity observed

    Time frame: 1 month, 6 months and 12 months

  5. Rate of Endoleaks

    Device effectiveness will be measured by the rate of Endoleaks reported

    Time frame: 1 month, 6 months and 12 months

  6. Rate of Aneurysm Sac Size Changes

    Device effectiveness will be measured by the rate of Aneurysm Sac Size Changes at 6 months and 12 months as compared to the first post-procedure imaging

    Time frame: 6 months and 12 months

  7. Rate of Limb Ischemia

    Device effectiveness will be measured by the rate of Limb Ischemia resulting in limb loss

    Time frame: 1 month, 6 months and 12 months

  8. Rate of Vascular Access Complications

    Device effectiveness will be measured by the rate of Vascular Access Complications

    Time frame: 1 month, 6 months and 12 months

  9. Rate of unintentional covering of renal arteries and / or hypogastric arteries

    Device effectiveness will be measured by the rate of unintentional covering of renal arteries and / or hypogastric arteries during the index procedure

    Time frame: Procedure / Study Day 0

Other outcomes

  1. Summary results of procedural data and outcomes

    Procedural data and outcomes will be summarized descriptively, including: * Type of anesthesia * Duration of procedure time (first cut to last stitch) * Time in ICU * Duration of hospitalization * Volume of blood loss * Volume of blood replaced * Subjects requiring blood transfusion * Type of arterial access (percutaneous, cut down) * Reinterventions

    Time frame: 1 month, 6 months and 12 months

06

Study locations

32 sites
  • Hospital Barros Luco Trudeau
    Santiago, Chile
  • Hospital de la Dirección de Previsión de Carabineros de Chile
    Santiago, Chile
  • Rigshospitalet, National Hospital and University of Copenhagen
    Copenhagen, Denmark
  • Deutsches Herzzentrum Berlin
    Berlin, Germany
  • Bonifatius Hospital
    Lingen, Germany
  • Theresienkrankenhaus und St. Hedwig-Klinik
    Mannheim, Germany
  • Universitätsklinikum Tübingen
    Tübingen, Germany
  • Evaggelismos General Hospital
    Athens, Greece
  • Georgios Gennimatas Thessaloniki General Hospital
    Thessaloníki, Greece
  • Queen Mary Hospital, University of Hong Kong
    Hong Kong, Hong Kong
  • Semmelweis Medical University Budapest
    Budapest, Hungary
  • Cork University Hospital
    Cork, Ireland
  • Casa Di Cura Villa Dei Fiori
    Acerra, Italy
  • Azienda Ospedaliera San Camillo Forlanini
    Roma, Italy
  • Azienda Ospedaliera Universitaria Senese
    Siena, Italy
  • ZiekenhuisGroep Twente
    Almelo, Netherlands
  • Universitair Medisch Centrum Utrecht
    Utrecht, Netherlands
  • Haukeland University Hospital
    Bergen, Norway
  • Samodzielny Publiczny Szpital Kliniczny Nr 1
    Lublin, Poland
  • Hospital HM Modelo
    A Coruña, Spain
  • Hospital Germans Trias i Pujol
    Badalona, Spain
  • Hospital Clínic de Barcelona
    Barcelona, Spain
  • Hospital Universitario Ramón y Cajal
    Madrid, Spain
  • Complexo Hospitalario Universitario de Ourense
    Ourense, Spain
  • Linköping University Hospital
    Linköping, Sweden
  • Karolinska University Hospital
    Solna, Sweden
  • Lampang Hospital
    Lampang, Thailand
  • Addenbrooke's Hospital, Cambridge University Hospitals
    Cambridge, United Kingdom
  • Manchester Royal Infirmary, Central Manchester University Hospitals
    Manchester, United Kingdom
  • John Radcliffe Hospital, Oxford University Hospitals
    Oxford, United Kingdom
  • Instituto Urológico San Román
    Caracas, Venezuela
  • Cho Ray Hospital
    Ho Chi Minh City, Vietnam
07

References and documents

Publications

  • 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. PubMed 31690524 ↗
  • 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. PubMed 30280649 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03449875
Lead sponsor
Bolton Medical
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
Feb 5, 2014
Primary completion
Apr 11, 2017
Completion
Apr 11, 2017
Last update
Jun 26, 2020

Study contacts

Carlo Setacci, MD, PhD
study chair · Department of Medicine, Surgery and Neuroscience, University of Siena Viale Bracci 1, 53100 Siena, Italy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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