TriVascular Post-Market Registry

NCT01372709 | Completed DMC

• 1 other identifier: 771-0008
• Study Type: observational
• Target: 501
• Locations: 8 countries
• Sites: 30

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

abdominal; aortic; aneurysm

Outcome Measures

Primary Outcomes (1)

• Treatment Success at 12 Months Post-Implantation/surgery.

  The primary endpoint is treatment success at 12 months post-implantation/surgery. Treatment success is defined as a composite technical endpoint composed of successful introduction and deployment of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System at the initial implantation procedure along with clinical endpoints of absence from type I or III endoleaks, aneurysm expansion, aneurysm rupture, conversion to open surgical repair, graft migration, and graft occlusion at 12 months post-implantation procedure.

  12 Months

Secondary Outcomes (1)

• Safety and Performance Endpoints

  1, 6, &12 Months

Study Arms (1)

Ovation™ or Ovation Prime™ Abdominal Stent Graft System

Adult male and female patients will be consecutively screened for the study. Eligible patients must meet all of the inclusion criteria and none of the exclusion criteria.

Device: Ovation™ or Ovation Prime™ Abdominal Stent Graft System

Interventions

Ovation™ or Ovation Prime™ Abdominal Stent Graft System DEVICE

Single occurrence permanent implant of AAA device.

Ovation™ or Ovation Prime™ Abdominal Stent Graft System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TriVascular, Inc.: lead

Study Sites (30)

Medical University of Vienna Dept. for Radiology, Section for Cardiovascular and Interventional Radiology

Vienna, Austria

Location

O.L. Vrouwziekenhuis

Aalst, Belgium

Location

Imelda Ziekenhuis

Bonheiden, Belgium

Location

Flanders Medical Research Program

Dendermonde, Belgium

Location

Universiteit Gent

Ghent, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

Groupe Hospitalier Edouard Herriot

Lyon, France

Location

Hôpital Paul d'Egine

Paris, France

Location

Park Hospital Leipzig, Strümpellstr. 41

Leipzig, Western Saxony Land, 04289, Germany

Location

Herz- und Gefässzentrum Bad Bevensen

Bad Bevensen, Germany

Location

Franziskus-Krankenhaus Berlin

Berlin, Germany

Location

Cardiovascular Center

Frankfurt, Germany

Location

Universitäres Herz und Gefaßzentrum Hamburg

Hamburg, Germany

Location

Städtisches klinikum Karlsruhe Klinik für Gefäß- und Thoraxchirurgie

Karlsruhe, Germany

Location

"CA Gefäßchirurgie Theresienkrankenhaus/St. Hedwig"

Mannheim, Germany

Location

Attikon Hospital

Athens, Greece

Location

Ospedale San Raffaele

Milan, Italy

Location

Policlinico San Donato

Milan, Italy

Location

Ospedale Civico Palermo

Palermo, Italy

Location

Ospedale Bianchi Melacrino Morelli

Reggio Calabria, Italy

Location

Azienda Ospedaliera Sant'Andrea

Roma, Italy

Location

Ospedale San Giovanni Addolorata

Roma, Italy

Location

Università La Sapienza/Policlinico Umberto I

Roma, Italy

Location

Univeristà La Sapienza/Policlinico Umberto I

Rome, Italy

Location

Ospedale San Giovanni Bosco

Torino, Italy

Location

A.O. Ospedale di Circolo e Fondazione Macchi

Varese, Italy

Location

Södersjukhuset

Stockholm, Sweden

Location

Frimley Park Hospital NHS Foundation Trust

Frimley, United Kingdom

Location

St. George's Vascular Institute

London, United Kingdom

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

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

Study Record Dates

• First Submitted: June 10, 2011
• First Posted: June 14, 2011
• Study Start: May 1, 2011
• Primary Completion: December 12, 2014
• Study Completion: June 14, 2019
• Last Updated: June 4, 2021

Record last verified: 2021-06

Locations

BE (5); FR (2); AU (1); GB (3); IT (10); SE (1); DE (7); GR (1)