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

Abdominal Aortic Aneurysm Clinical Trial

— RATIONALE  

Official title:

A Post-Market Surveillance Clinical Registry of the TREOVANCE® Stent-Graft for Patients With Infrarenal Abdominal Aortic Aneurysms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03449875
• Other study ID #: IP-0024-17
• Status: Completed
• Start date: February 5, 2014
• Est. completion date: April 11, 2017

Study information

• Verified date: June 2020
• Source: Bolton Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: April 11, 2017
• Est. primary completion date: April 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• TREOVANCE® Stent-Graft with Navitel® Delivery System
Endovascular repair of abdominal aortic aneurysms.

Locations

Country	Name	City	State
Chile	Hospital Barros Luco Trudeau	Santiago
Chile	Hospital de la Dirección de Previsión de Carabineros de Chile	Santiago
Denmark	Rigshospitalet, National Hospital and University of Copenhagen	Copenhagen
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Bonifatius Hospital	Lingen
Germany	Theresienkrankenhaus und St. Hedwig-Klinik	Mannheim
Germany	Universitätsklinikum Tübingen	Tübingen
Greece	Evaggelismos General Hospital	Athens
Greece	Georgios Gennimatas Thessaloniki General Hospital	Thessaloníki
Hong Kong	Queen Mary Hospital, University of Hong Kong	Hong Kong
Hungary	Semmelweis Medical University Budapest	Budapest
Ireland	Cork University Hospital	Cork
Italy	Casa Di Cura Villa Dei Fiori	Acerra
Italy	Azienda Ospedaliera San Camillo Forlanini	Roma
Italy	Azienda Ospedaliera Universitaria Senese	Siena
Netherlands	ZiekenhuisGroep Twente	Almelo
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Norway	Haukeland University Hospital	Bergen
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1	Lublin
Spain	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
Sweden	Linköping University Hospital	Linköping
Sweden	Karolinska University Hospital	Solna
Thailand	Lampang Hospital	Lampang
United Kingdom	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
Venezuela	Instituto Urológico San Román	Caracas
Vietnam	Cho Ray Hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Bolton Medical

Countries where clinical trial is conducted

Chile,  Denmark,  Germany,  Greece,  Hong Kong,  Hungary,  Ireland,  Italy,  Netherlands,  Norway,  Poland,  Spain,  Sweden,  Thailand,  United Kingdom,  Venezuela,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	1 month, 6 months and 12 months
Primary	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	Rate of Device Delivery/Deployment Success	Device effectiveness will be measured through the rate of successful delivery and deployment during the index procedure	Procedure / Study Day 0
Secondary	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	6 months and 12 months
Secondary	Rate of Stent-Graft Patency	Device effectiveness will be measured by the rate of Stent-Graft Patency observed	1 month, 6 months and 12 months
Secondary	Rate of Stent-Graft Integrity	Device effectiveness will be measured by the rate of Stent-Graft Integrity observed	1 month, 6 months and 12 months
Secondary	Rate of Endoleaks	Device effectiveness will be measured by the rate of Endoleaks reported	1 month, 6 months and 12 months
Secondary	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	6 months and 12 months
Secondary	Rate of Limb Ischemia	Device effectiveness will be measured by the rate of Limb Ischemia resulting in limb loss	1 month, 6 months and 12 months
Secondary	Rate of Vascular Access Complications	Device effectiveness will be measured by the rate of Vascular Access Complications	1 month, 6 months and 12 months
Secondary	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	Procedure / Study Day 0