Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) for Extensive Aortoiliac Occlusive Disease

Aorto-Iliac Atherosclerosis Clinical Trial

Official title:

Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) for Extensive Aortoiliac Occlusive Disease A Multicenter, Prospective Investigator Initiated Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03767686
• Other study ID #: CERAB trial
• Status: Terminated
• Start date: March 23, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: March 2020
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Endovascular treatment is rapidly taking over surgery for aorto-iliac occlusive disease (AOID), also in extensive pathology. This is related to its minimally invasiveness, decreasing the procedural morbidity rate. When the aortic bifurcation was involved in the lesion, the patency rates of kissing stents configurations were often inferior to open repair. In 2013 the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) technique was introduced in an attempt to improve endovascular treatment results by a more anatomical and physiological reconstruction, with a subsequent improved clinical outcome.

This investigator-initiated multicenter trial will prospectively record all data on performed CERAB procedures using the Bentley balloon expandable covered stents (BeGraft Aortic and BeGraft Peripheral) in multiple International sites, in order to gain more robust real-world data on the efficacy of these stent grafts for this indication.

Consecutive patients in whom a CERAB will be performed with these particular covered stents in the participating centers.

Main study parameters/endpoints: The primary end-point of this study is technical success. Patency rates, peri-procedural morbidity, clinical improvement, quality of life, clinically-driven target vessel revascularization and reintervention-rate will be secondary outcome measures. Overall, patients will be followed for 5 years

Description:

Endovascular treatment is rapidly taking over surgery for aorto-iliac occlusive disease (AOID) also for complex lesions. This is related to the minimally invasiveness of the procedure decreasing the morbidity rate. Patency results of endovascular treatment were often inferior compared to open repair when the aortic bifurcation was involved in the lesion. In 2013 Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) technique was introduced in an attempt to improve endovascular treatment results by a more anatomical and physiological reconstruction, with a subsequent better clinical outcome. The early results of the CERAB configuration are promising with primary, primary-assisted and secondary patency of, respectively 86.2%/91.1%/97.0% at 1-year, 83.9%/88.7%/97.0% at 2-year and 82.1%/86.8%/97.0% at 3-year FU in a group of 130 patients, including the first in man results. The vast majority (89.2%) were TASC-II D lesions and the 30-day major complication rate was 7.7%.

This trial is designed to prospectively collect all data on implanted CERAB configurations, using the balloon expandable stents from Bentley InnoMed, in a defined group of aorto-iliac pathology in multiple international sites in order to gain more insight in the outcome of the technique. Technical success will be the primary endpoint. Other evaluations will include patency rates, quality of life, the reintervention-rate, 30-day morbidity and target vessel revascularization up to 5 years after treatment.

A total of 145 patients will be included and followed until 5 years of follow-up. A core lab will independently analyze the images (CT scan or duplex) which will be made at the following time points: pre-op, 1 month, 6 months, 1 year and yearly up to 5 years of follow-up.

Additionally, at these time points three questionnaires will be completed by the patients. These questionnaires are about walking ability (WIQ), and quality of life (EQ-5D and WHOQoL-BREF).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Provided written informed consent

• Clinical necessity for treatment

• Eligible anatomy for CERAB without the need for chimney's

• TASC-2 classification as assigned in the study protocol (specified type B, C and D lesions)

Exclusion Criteria:

• Patient is participating in another conflicting clinical study

• Patient's life expectancy <2 years as judged by the investigator

• Patient has a psychiatric or other condition that may interfere with the study

• Patient has a known allergy to any device component

• Patients with a systemic infection who may be at increased risk of endovascular graft infection.

• Patient has a coagulopathy or uncontrolled bleeding disorder

• Patient had a CVA or an MI within the prior three months

• Patient is pregnant (Female patients of childbearing potential only)

Related Conditions & MeSH terms

• Aorto-Iliac Atherosclerosis
• Aortoiliac Obstruction
• Atherosclerosis
• Leriche Syndrome

Locations

Country	Name	City	State
Australia	Dandenong Hospital	Victoria Point
Italy	A.O.U. Città della Salute e della Scienza di Torino	Torino
Mexico	Spanish Hospital	Mexico City
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	Dijklander Ziekenhuis	Hoorn
Netherlands	Medical University Center Maastricht	Maastricht
New Zealand	Auckland City Hospital	Auckland
New Zealand	Waikato Hospital	Hamilton

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Countries where clinical trial is conducted

Australia,  Italy,  Mexico,  Netherlands,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success	Technical success is defined as successful implantation of the CERAB device without occlusion during the first 30-days after implantation	Up to 30 days
Primary	Primary patency	Primary patency at 12 months measured by duplex ultrasound	Up to 12 months
Primary	Technical success	Technical success is defined as successful implantation of the CERAB device without conversion to open repair	Up to 30 days
Secondary	Technical success	Patency rates measured by duplex ultrasound	Up to 5 years of follow-up
Secondary	Technical success	Target vessel revascularization measured by duplex ultrasound	Up to 5 years of follow-up
Secondary	Technical success	Conversion to open surgery judged at every clinic visit by the investigator	Up to 5 years of follow-up
Secondary	Clinical success	Freedom from reinterventions judged at every clinic visit by the investigator	Up to 5 years of follow-up
Secondary	Clinical success	30 days morbidity judged at every clinic visit by the investigator	Up to 30 days of follow-up
Secondary	Clinical success	Incidence serious adverse events device related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator	Up to 3 months of follow-up
Secondary	Clinical success	Incidence serious adverse events device related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator	Up to 6 months of follow-up
Secondary	Clinical success	Incidence serious adverse events device related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator	Up to 12 months of follow-up
Secondary	Clinical success	Incidence of serious adverse events procedure related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator	Up to 3 months of follow-up
Secondary	Clinical success	Incidence of serious adverse events procedure related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator	Up to 6 months of follow-up
Secondary	Clinical success	Incidence of serious adverse events procedure related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator	Up to 12 months of follow-up
Secondary	Clinical success	Overall survival investigated with every clinic visit, done by the investigator	Up to 5 years of follow-up
Secondary	Clinical success	Reintervention-free survival investigated with every clinic visit, done by the investigator	Up to 5 years of follow-up
Secondary	Clinical success	Clinical improvement as measured by the Rutherford category of which 1 is better dan 6	Up to 5 years of follow-up
Secondary	Clinical success	Patient reported outcomes measured by the EQ-5D questionnaire	Up to 5 years of follow-up
Secondary	Clinical success	Patient reported outcomes measured by the Walking Impairment Questionnaire	Up to 5 years of follow-up
Secondary	Clinical success	Patient reported outcomes measured by the WHOQoL Bref	Up to 5 years of follow-up