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

NCT03449875 | Completed

• 1 other identifier: IP-0024-17
• Study Type: observational
• Target: 202
• Locations: 17 countries
• Sites: 32

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.

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

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

  Through 12 months

Secondary Outcomes (9)

• Rate of Device Delivery/Deployment Success

  Procedure / Study Day 0

• Rate of Stent-Graft Migration greater than 10mm

  6 months and 12 months

• Rate of Stent-Graft Patency

  1 month, 6 months and 12 months

• Rate of Stent-Graft Integrity

  1 month, 6 months and 12 months

• Rate of Endoleaks

  1 month, 6 months and 12 months

Other Outcomes (1)

• Summary results of procedural data and outcomes

  1 month, 6 months and 12 months

Interventions

TREOVANCE® Stent-Graft with Navitel® Delivery System DEVICE

Endovascular repair of abdominal aortic aneurysms.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects diagnosed with infrarenal aortic aneurysms requiring endovascular repair.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Bolton Medical: lead

Study Sites (32)

Hospital Barros Luco Trudeau

Santiago, Chile

Location

Hospital de la Dirección de Previsión de Carabineros de Chile

Santiago, Chile

Location

Rigshospitalet, National Hospital and University of Copenhagen

Copenhagen, Denmark

Location

Deutsches Herzzentrum Berlin

Berlin, Germany

Location

Bonifatius Hospital

Lingen, Germany

Location

Theresienkrankenhaus und St. Hedwig-Klinik

Mannheim, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

Evaggelismos General Hospital

Athens, Greece

Location

Georgios Gennimatas Thessaloniki General Hospital

Thessaloniki, Greece

Location

Queen Mary Hospital, University of Hong Kong

Hong Kong, Hong Kong

Location

Semmelweis Medical University Budapest

Budapest, Hungary

Location

Cork University Hospital

Cork, Ireland

Location

Casa Di Cura Villa Dei Fiori

Acerra, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Roma, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, Italy

Location

ZiekenhuisGroep Twente

Almelo, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Location

Haukeland University Hospital

Bergen, Norway

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1

Lublin, Poland

Location

Hospital HM Modelo

A Coruña, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Complexo Hospitalario Universitario de Ourense

Ourense, Spain

Location

Linköping University Hospital

Linköping, Sweden

Location

Karolinska University Hospital

Solna, Sweden

Location

Lampang Hospital

Lampang, Thailand

Location

Addenbrooke's Hospital, Cambridge University Hospitals

Cambridge, United Kingdom

Location

Manchester Royal Infirmary, Central Manchester University Hospitals

Manchester, United Kingdom

Location

John Radcliffe Hospital, Oxford University Hospitals

Oxford, United Kingdom

Location

Instituto Urológico San Román

Caracas, Venezuela

Location

Cho Ray Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (2)

• 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.

  PMID: 31690524 DERIVED

• 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.

  PMID: 30280649 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Carlo Setacci, MD, PhD

  Department of Medicine, Surgery and Neuroscience, University of Siena Viale Bracci 1, 53100 Siena, Italy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: February 28, 2018
• Study Start: February 5, 2014
• Primary Completion: April 11, 2017
• Study Completion: April 11, 2017
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

HU (1); SE (2); IE (1); PL (1); NL (2); ES (5); TH (1); NO (1); IT (3); VE (1); GB (3); GR (2); VN (1); DK (1); HK (1); DE (4); CL (2)