A Mid- to Long-term Post-Market Clinical Follow-up Study of Bolton Medical Abdominal Stent-Grafts for Patients with Infrarenal Abdominal Aortic Aneurysms

A Mid- to Long-term Post-Market Clinical Follow-up Study of Bolton Medical Abdominal Stent-Grafts for Patients with Infrarenal Abdominal Aortic Aneurysms - INTEGRITY

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00015728

Enrollment

220

Registered

2018-11-22

Start date

2018-12-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I71.4

Interventions

Group 1: Patients diagnosed with abdominal Aortic Aneurysm and with implanted infrarenal abdominal TREO or TREOVANCE Stentgraft from Bolton Medical

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients that have received or will receive a TREO or TREOVANCE Stentgraft Implantation

Exclusion criteria

Exclusion criteria: Refusal to participate

Design outcomes

Primary

Measure	Time frame
Stent-graft integrity (defined as absence of fracture) one year post-implant as measured by a core lab. In accordance with standard reporting requirements, the integrity of an endovascular device may be compromised at the time of deployment (early device failure) or at some later date after graft implantation (late device failure). The recommended system for grading late deformation of endografts is as follows: Grade 0, no device deformation; Grade I, devices with induced curvature, without acute angulation; Grade II, angulation more than 30 degrees; and Grade III, angulation more than 30 degrees in association with device obstruction (IIIa) or component module disconnection (IIIb). The presence or absence of clinical sequelae resulting from any fracture will be detailed in each case.	—

Measure

Time frame

Stent-graft integrity (defined as absence of fracture) one year post-implant as measured by a core lab. In accordance with standard reporting requirements, the integrity of an endovascular device may be compromised at the time of deployment (early device failure) or at some later date after graft implantation (late device failure). The recommended system for grading late deformation of endografts is as follows: Grade 0, no device deformation; Grade I, devices with induced curvature, without acute angulation; Grade II, angulation more than 30 degrees; and Grade III, angulation more than 30 degrees in association with device obstruction (IIIa) or component module disconnection (IIIb). The presence or absence of clinical sequelae resulting from any fracture will be detailed in each case.

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Secondary

Measure	Time frame
Stent-graft integrity (including absence of fracture, graft tears or holes, broken sutures, kinking or twisting leading to occlusion or ischemia) at any time. Clinical success: successful deployment of the device at the intended location without death as a result of aneurysm-related treatment, type I or III endoleak, graft infection or thrombosis, aneurysm expansion (diameter =5 mm), aneurysm rupture, or conversion to open repair. Clinical success will be claimed for those cases with a type II endoleak only in the absence of aneurysm expansion (diameter =5 mm). In addition and in accordance with standard reporting requirements, the clinical significance of device failures will be stratified as: 0, not associated with an adverse clinical event or necessitating increased surveillance or intervention; 1, necessitating increased surveillance but without clinical event; 2, necessitating intervention to control or manage; and 3, resulting in conversion, rupture, severe complication or death (27) Migration, endoleaks, component separation, and aneurysm/iliac aneurysm sac size changes (increase and decrease) will be detailed. Survival rates will be reported along with all-cause mortality and aneurysm-related mortality. The following secondary endpoints will be assessed for preliminary performance at all follow-up time points: Specifically, migration will be evaluated using the standard reporting grading system as below: Endograft migration (as defined by protocol relative to anatomical landmarks or any migration leading to symptoms or requiring therapy) 1 No evidence of endoleak, graft obstruction, or aneurysm expansion 2 Secondary endovascular treatment 3 Explantation necessitated, aneurysm rupture, death Additionally, the distance migrated will be measured. If an exact measurement is not possible, it will be estimated as follows: Between 5 and 10 mm = 10 mm Not measured Endoleaks (persistence of blood flow abluminal to the endovascular prosthesis) will also ev	—

Measure

Time frame

Stent-graft integrity (including absence of fracture, graft tears or holes, broken sutures, kinking or twisting leading to occlusion or ischemia) at any time. Clinical success: successful deployment of the device at the intended location without death as a result of aneurysm-related treatment, type I or III endoleak, graft infection or thrombosis, aneurysm expansion (diameter =5 mm), aneurysm rupture, or conversion to open repair. Clinical success will be claimed for those cases with a type II endoleak only in the absence of aneurysm expansion (diameter =5 mm). In addition and in accordance with standard reporting requirements, the clinical significance of device failures will be stratified as: 0, not associated with an adverse clinical event or necessitating increased surveillance or intervention; 1, necessitating increased surveillance but without clinical event; 2, necessitating intervention to control or manage; and 3, resulting in conversion, rupture, severe complication or death (27) Migration, endoleaks, component separation, and aneurysm/iliac aneurysm sac size changes (increase and decrease) will be detailed. Survival rates will be reported along with all-cause mortality and aneurysm-related mortality. The following secondary endpoints will be assessed for preliminary performance at all follow-up time points: Specifically, migration will be evaluated using the standard reporting grading system as below: Endograft migration (as defined by protocol relative to anatomical landmarks or any migration leading to symptoms or requiring therapy) 1 No evidence of endoleak, graft obstruction, or aneurysm expansion 2 Secondary endovascular treatment 3 Explantation necessitated, aneurysm rupture, death Additionally, the distance migrated will be measured. If an exact measurement is not possible, it will be estimated as follows: Between 5 and 10 mm = 10 mm Not measured Endoleaks (persistence of blood flow abluminal to the endovascular prosthesis) will also ev

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Countries

Germany

Contacts

Public ContactJörg Teßarek

Bonifatius Hospital Lingen gGmbHAbteilung für Gefäßchirurgie

hartmut.goertz@hospital-lingen.de0049 (0)591 910-6121

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026