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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02480595




Registration number
NCT02480595
Ethics application status
Date submitted
22/06/2015
Date registered
24/06/2015
Date last updated
24/06/2015

Titles & IDs
Public title
AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft
Scientific title
ARCHYTAS: AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft
Secondary ID [1] 0 0
ARCHYTAS
Universal Trial Number (UTN)
Trial acronym
ARCHYTAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysms 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Stent Graft

EVAR - Patients undergoing endovascular repair with the latest generation Aorfix™ AAA Flexible Stent Graft System for treatment of abdominal aortic and aorto-iliac aneurysms where the aorta in the aneurysm neck is bent through an angle between 0° and 90°


Treatment: Devices: Stent Graft
Endovascular repair of abdominal aortic aneurysm (EVAR)

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment Success - Defined as freedom from the following:
Sac expansion > 5mm
Type I and III endoleaks requiring re-intervention
Rupture
Conversion to open surgery
Stent graft migration > 10 mm
Stent graft occlusion
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Graft Performance - Defined as:
Stent graft migration > 10mm (12 months)
Stent graft patency (12 months)
Stent graft endoleaks (30 days and 12 months)
Aneurysm-related secondary procedure (12 months)
Adverse device effects (12 months)
Technical observations (12 months)
Aneurysm-related mortality (12 Months)
All-cause mortality (30 days and 12 months)
Major Adverse Events (MAEs) (30 days)
Timepoint [1] 0 0
30 Days to 12 Months

Eligibility
Key inclusion criteria
1. Diagnosed abdominal aortic aneurysm with indication for endovascular repair.

2. Intention to electively implant the Aorfix™ Stent Graft System.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Does not comply with the indications for Aorfix™ in the Instructions for Use (IFU).

2. Unwillingness or inability to comply with the recommended follow-up assessments
according to the standards of care at the investigative site.

3. Unwillingness or inability to provide informed consent to both the Registry and the
EVAR procedure.

4. Patients in whom Aorfix™ is being placed as a secondary procedure to a previous
surgical or endovascular treatment of an AAA other than with another Aorfix™ graft.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Czech Republic
State/province [1] 0 0
Prague
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Germany
State/province [3] 0 0
Essen
Country [4] 0 0
Germany
State/province [4] 0 0
Frankfurt
Country [5] 0 0
Germany
State/province [5] 0 0
Halle
Country [6] 0 0
Germany
State/province [6] 0 0
Köln
Country [7] 0 0
Germany
State/province [7] 0 0
Leipzig
Country [8] 0 0
Germany
State/province [8] 0 0
Limburg
Country [9] 0 0
Germany
State/province [9] 0 0
Lingen
Country [10] 0 0
Germany
State/province [10] 0 0
München
Country [11] 0 0
Germany
State/province [11] 0 0
Westerstede
Country [12] 0 0
Germany
State/province [12] 0 0
Wuerzburg
Country [13] 0 0
Italy
State/province [13] 0 0
Bergamo
Country [14] 0 0
Italy
State/province [14] 0 0
Como
Country [15] 0 0
Italy
State/province [15] 0 0
Lodi
Country [16] 0 0
Italy
State/province [16] 0 0
Perugia
Country [17] 0 0
Italy
State/province [17] 0 0
Rome
Country [18] 0 0
Italy
State/province [18] 0 0
San Donato
Country [19] 0 0
New Zealand
State/province [19] 0 0
Auckland
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Spain
State/province [21] 0 0
Cantabria
Country [22] 0 0
Spain
State/province [22] 0 0
Cádiz
Country [23] 0 0
Spain
State/province [23] 0 0
Girona
Country [24] 0 0
Spain
State/province [24] 0 0
Granada
Country [25] 0 0
Spain
State/province [25] 0 0
Madrid
Country [26] 0 0
Spain
State/province [26] 0 0
Ourense
Country [27] 0 0
Spain
State/province [27] 0 0
Palma de Mallorca
Country [28] 0 0
Spain
State/province [28] 0 0
San Sebastián
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Bournemouth
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Bristol
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Chelmsford
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Harrow
Country [33] 0 0
United Kingdom
State/province [33] 0 0
London
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Norwich
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Nottingham
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Preston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Lombard Medical
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective,
registry designed to collect "on-label" data in real world clinical settings on patients
undergoing endovascular repair with the latest generation Aorfix™ AAA Flexible Stent Graft
System. Registry data will augment existing data from ongoing and prospective Aorfix™
clinical trials for the purposes of publication, general product development and quality
measures.
Trial website
https://clinicaltrials.gov/show/NCT02480595
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vicente Riambau
Address 0 0
University Clinic, Barcelona, Spain
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lea Doyle
Address 0 0
Country 0 0
Phone 0 0
(352) 591-0893
Fax 0 0
Email 0 0
lea.doyle@lombardmedical.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02480595