Abdominal Aortic AneurysmsARCHYTASNCT02480595
AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft
An observational study of Abdominal Aortic Aneurysms, run by Lombard Medical at 37 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Aortic Aneurysms
- What is being tested?
- Stent Graft
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 37 sitesin 6 countries
- Study dates
- Apr 2015to Apr 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The ARCHYTAS Registry will meet objectives only if appropriate patients are enrolled. Patients presenting with AAA who fulfill inclusion criteria and are not ruled out by exclusion criteria will be included. Each investigator will record all potential participants screened for inclusion and document reasons for ineligibility. The implanting physician will consider all relevant medical and nonmedical factors when determining if a particular patient is suitable for inclusion in the Registry. In order to prevent selection bias, sites will be asked to screen and enroll patients consecutively. In circumstances where patients are screened and subsequently enrolled, but for various reasons are not implanted with the Aorfix™ device, only the screening and procedural data will be collected.
Who may be able to join
- Diagnosed abdominal aortic aneurysm with indication for endovascular repair.
- Intention to electively implant the Aorfix™ Stent Graft System.
Who cannot join
- Does not comply with the indications for Aorfix™ in the Instructions for Use (IFU).
- Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care at the investigative site.
- Unwillingness or inability to provide informed consent to both the Registry and the EVAR procedure.
- 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.
Trial locations and contacts
37 sites in 6 countries.
37 sites in 6 countries
Germany12 sites
Charité - Universitätsmedizin Berlin
Berlin, 13353
Universitätsklinikum Herzzentrum Köln
Cologne, 50924
Alfried Krupp Krankenhaus
Essen, 45131
Elisabeth-Krankenhaus Essen
Essen, 45134
Universitätsklinikum Frankfurt
Frankfurt, 60590
University Hospital Halle
Halle, 06120
Universitätsklinikum Leipzig
Leipzig, 04103
St.Vincenz-Krankenhaus Limburg
Limburg, 65549
Bonifatius Hospital
Lingen, 49808
Klinikum Rechts der Isar der TU München
München, 81675
Ammerland Klinik GmbH
Westerstede, 26655
Universitätsklinikum Würzburg
Würzburg, 97080
Spain9 sites
University Clinic
Barcelona, 8036
Hospital Universitario Puerta del Mar
Cadiz, 11009
H. Universitari Dr. Josep Trueta
Girona, 17007
University Hospital S. Cecilio
Granada, 18012
HGU Gregorio Marañon
Madrid, 28007
Complexo Hospitalario Universitario de Ourense
Ourense, 32005
H. Universitari Son Espases
Palma de Mallorca, 07120
Hospital Universitario Donostia
San Sebastián, 20014
H. Marqués de Valdecilla
Santander, 39008
United Kingdom8 sites
Royal Bournemouth General Hospital
Bournemouth, BH7 7DW
Southmead Hospital
Bristol, BS10 5NB
Mid Essex Hospital - Broomfield
Chelmsford, CM1 7ET
Northwick Park Hospital
Harrow, HA1 3UJ
Kings College Hospital NHS Foundation Trust
London, SE5 9RS
Norfolk & Norwich University Hospital
Norwich, NR4 7UY
Nottingham University Hospital
Nottingham, NG7 2UH
Royal Preston Hospital
Preston, PR2 9HT
Italy6 sites
Ospedale Papa Giovanni 23
Bergamo, 21100
Sant'Anna
Como, 22020
Ospeale Maggiore
Lodi, 26900
Ospedale Sant'Andrea delle Fratte
Perugia, 06100
Tor Vergata
Rome
Policlinico San Donato IRCCS
San Donato, 20097
About this study
Official title: ARCHYTAS: AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft
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.
Read the detailed description
The ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective, registry established by Lombard Medical Ltd. (Lombard) 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, for treatment of abdominal aortic and aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0° and 90°. This indication for Aorfix™ is approved in all territories where this Registry is being operated and this Registry does not seek to collect data on any use of the implant for which full commercial approval does not already exist.
The ARCHYTAS Registry data will augment existing data from ongoing and prospective clinical trials with Aorfix™ for the purposes of publication, general product development and quality measures.
- Conditions
- Abdominal Aortic Aneurysms
- Being tested
- Stent Graft
- Keywords
- Abdominal Aortic Aneurysm, AAA, Endovascular, EVAR, Stent, Stent Graft, High Angle, Tortuous
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent GraftDevice
Also called Aorfix™ stent, Aorfix™ stent graft
Endovascular repair of abdominal aortic aneurysm (EVAR)
| Study group | Role | What they receive |
|---|---|---|
| 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° Receives: Device: Stent Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
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)
Measured: 30 Days to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Why it stopped: Recruitment on hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Lombard Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vicente Riambau, Principal investigator, University Clinic, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480595
- Sponsor's protocol ID
- ARCHYTAS
- Acronym
- ARCHYTAS
- Status last verified
- Oct 2021
- First submitted
- 22 Jun 2015
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARCHYTAS: AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft
- ClinicalTrials.gov ID
- NCT02480595
- Acronym / sponsor ID
- ARCHYTAS / ARCHYTAS
- Conditions
- Abdominal Aortic Aneurysms
- Keywords
- Abdominal Aortic Aneurysm, AAA, Endovascular, EVAR, Stent, Stent Graft, High Angle, Tortuous
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Recruitment on hold
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Lombard MedicalIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective, registry established by Lombard Medical Ltd. (Lombard) 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, for treatment of abdominal aortic and aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0° and 90°. This indication for Aorfix™ is approved in all territories where this Registry is being operated and this Registry does not seek to collect data on any use of the implant for which full commercial approval does not already exist.
The ARCHYTAS Registry data will augment existing data from ongoing and prospective clinical trials with Aorfix™ for the purposes of publication, general product development and quality measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVAR | – | Device: Stent GraftPatients 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° |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The ARCHYTAS Registry will meet objectives only if appropriate patients are enrolled. Patients presenting with AAA who fulfill inclusion criteria and are not ruled out by exclusion criteria will be included. Each investigator will record all potential participants screened for inclusion and document reasons for ineligibility. The implanting physician will consider all relevant medical and nonmedical factors when determining if a particular patient is suitable for inclusion in the Registry. In order to prevent selection bias, sites will be asked to screen and enroll patients consecutively. In circumstances where patients are screened and subsequently enrolled, but for various reasons are not implanted with the Aorfix™ device, only the screening and procedural data will be collected.
Key inclusion criteria (2 listed)
- Diagnosed abdominal aortic aneurysm with indication for endovascular repair.
- Intention to electively implant the Aorfix™ Stent Graft System.
Key exclusion criteria (4 listed)
- Does not comply with the indications for Aorfix™ in the Instructions for Use (IFU).
- Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care at the investigative site.
- Unwillingness or inability to provide informed consent to both the Registry and the EVAR procedure.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent GraftAlso: Aorfix™ stent, Aorfix™ stent graftEndovascular repair of abdominal aortic aneurysm (EVAR) | Device | EVAR |
Primary outcome
Treatment Success
Time frame: 12 months
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
1 secondary outcome
Graft Performance
Time frame: 30 Days to 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Lombard Medical Home PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vicente Riambau principal investigator
University Clinic, Barcelona, Spain
37 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysms, run by Lombard Medical at 37 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Germany, Spain, United Kingdom, Italy, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Success (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.