Clinical trial NCT01372709: TriVascular Post-Market Registry
Official title: A Post-Market Study to Evaluate the Safety and Performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Keywords: abdominal
aortic
aneurysm
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2011-06-14
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The Ovation™ or Ovation Prime™ Abdominal Stent Graft System study is a multicenter, prospective, observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study intends to expand the clinical evidence of the safety and performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in an all comers ("real world") patient population.

Brief summary: This is a prospective observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System ("Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market study is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in actual clinical practice following commercial approval.


Eligibility criteria: Inclusion Criteria:

* Subject is \> 18 years or minimum age as required by local regulations.
* Indication for elective repair of AAA with an endovascular stent graft in accordance with the Instructions for Use of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System.
* Subject has signed an Ethics Committee (EC) approved Informed Consent Form. The subject or legal representative has been informed of the nature of the study, has consented to participate, and has authorized the collection and release of his/her medical information.
* Subject intends to electively receive the Ovation™ or Ovation Prime™ Abdominal Stent Graft System.
* Subject has the ability and willingness to comply with all follow-up exams as indicated in clinical investigation plan.

Exclusion Criteria:

* Subject demonstrates high probability of non-adherence to physician's follow-up requirements.
* Subject's current participation in a concurrent randomized control trial (RCT) or investigational device/drug study which could confound study results.
* Life expectancy less than 1 year
* Pregnancy
* Subjects with poor renal function as indicated by a serum creatinine \> 2.5mg/dl.

Primary outcomes:
measure: Treatment Success at 12 Months Post-Implantation/surgery.
timeFrame: 12 Months
Secondary outcomes:
measure: Safety and Performance Endpoints
timeFrame: 1, 6, &12 Months
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Medical University of Vienna Dept. for Radiology, Section for Cardiovascular and Interventional Radiology
city: Aalst
country: Belgium
facility: O.L. Vrouwziekenhuis
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Dendermonde
country: Belgium
facility: Flanders Medical Research Program
city: Gent
country: Belgium
facility: Universiteit Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Lyon
country: France
facility: Groupe Hospitalier Edouard Herriot
city: Paris
country: France
facility: Hôpital Paul d'Egine
city: Leipzig
country: Germany
facility: Park Hospital Leipzig, Strümpellstr. 41
state: Western Saxony Land
city: Bad Bevensen
country: Germany
facility: Herz- und Gefässzentrum Bad Bevensen
city: Berlin
country: Germany
facility: Franziskus-Krankenhaus Berlin
city: Frankfurt
country: Germany
facility: Cardiovascular Center
city: Hamburg
country: Germany
facility: Universitäres Herz und Gefaßzentrum Hamburg
city: Karlsruhe
country: Germany
facility: Städtisches klinikum Karlsruhe Klinik für Gefäß- und Thoraxchirurgie
city: Mannheim
country: Germany
facility: "CA Gefäßchirurgie Theresienkrankenhaus/St. Hedwig"
city: Athens
country: Greece
facility: Attikon Hospital
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Milan
country: Italy
facility: Policlinico San Donato
city: Palermo
country: Italy
facility: Ospedale Civico Palermo
city: Reggio Calabria
country: Italy
facility: Ospedale Bianchi Melacrino Morelli
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea
city: Roma
country: Italy
facility: Ospedale San Giovanni Addolorata
city: Roma
country: Italy
facility: Università La Sapienza/Policlinico Umberto I
city: Rome
country: Italy
facility: Univeristà La Sapienza/Policlinico Umberto I
city: Torino
country: Italy
facility: Ospedale San Giovanni Bosco
city: Varese
country: Italy
facility: A.O. Ospedale di Circolo e Fondazione Macchi
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: St. George's Vascular Institute
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
Study officials:
References: