The objective of this clinical investigation is to evaluate the safety and performance of the BeGraft Aortic covered stent Graft System & the BeGraft Peripheral covered stent Graft System (Bentley Innomed, Hechingen, Germany) in CERAB…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary performance Endpoint:
1. Freedom from clinically-driven target lesion revascularization (CD-TLR) at
12 months, defined as freedom from repeat endovascular revascularization to
maintain or re-establish patency within the treated lesion.
Primary Safety Endpoint:
1. Incidence of Serious Adverse Device Effects (SADE) and procedure related
Serious Adverse Events (SAE) at 12 months follow up.
Secondary outcome
Secondary Performance Endpoints: 1. Technical success rate after procedure
defined as successful introduction and deployment of the study devices BeGraft
Aortic covered stent Graft System & the BeGraft Peripheral covered stent Graft
System (Bentley Innomed, Hechingen, Germany) for CERAB procedures 2. Freedom
for conversion to open surgical repair of the target lesion. 3. Patency rate of
the target vessel (primary, primary assisted and secondary). 4. Time to
re-vascularization/re-intervention. 5. Patient reported outcomes at 30 days
post-procedure, 6-, 12-, and 24-months compared to pre-procedure: a. Walking
Impairment Questionnaire (WIQ) b. Quality of Life Questionnaire (EQ-5D) 6.
Clinical success at every follow up visit, defined as an improvement of
Rutherford classification of one class or more compared to the pre-procedure
Rutherford classification. 7. Hemodynamic improvement defined as increase in
Ankle Brachial Index (ABI) of at least 0.10 compared to baseline ABI
(pre-procedure) at 30 days post-procedure, 6-, 12-, and 24-months. Secondary
Safety Endpoints: 1. Incidence of Serious Adverse Device Effects (SADE) and
procedure related Serious Adverse Events (SAE) at 1-, 6- and 24-months after
the procedure. 2. 30-day mortality. 3. Overall survival rate at up to 30-days
post-procedure, 6-, 12- and 24-months. 4. Incidence of Major Adverse Events
(MAE) at up to 30-days post-procedure, 6-, 12- and 24-months.
Background summary
Peripheral Arterial Disease (PAD) affects more than 200 million people
worldwide and is the leading cause of lower limb amputation . Aorto-iliac
atherosclerosis is common in patients with symptomatic PAD and therefore
aorto-iliac interventions, either surgical or endovascular, are often performed
in this patient population.
The CERAB technique was designed to achieve an improved anatomical and
physiological reconstruction of the aorto-iliac segment. The aim of the
procedure is to improve the results of endovascular reconstruction of this
anatomical region, especially in patients with occlusive and/or very calcified
atherosclerotic disease. First trials demonstrated that the CERAB technique is
a safe and feasible technique for the treatment of extensive aorto-iliac
occlusive disease (AIOD) with satisfying patency and clinical improvement,
especially in patients treated for TASC II D lesions.
Endovascular repair offers several benefits over conventional surgery, namely a
less invasive approach, faster recovery, lower morbidity, lower early
post-operative mortality and a lower rate of perioperative complications.
However, more long-term follow ups are required to confirm these promising
results
The hypothesis of the planned work is the safe implantation of the BeGraft
Peripheral Stent Graft System and BeGraft Aortic covered stent Graft system in
CERAB configuration for Aorto-iliac Occlusive Disease.
Study objective
The objective of this clinical investigation is to evaluate the safety and
performance of the BeGraft Aortic covered stent Graft System & the BeGraft
Peripheral covered stent Graft System (Bentley Innomed, Hechingen, Germany) in
CERAB configuration (Covered Endovascular Reconstruction of Aortic Bifurcation)
for Aorto-iliac Occlusive Disease.
Study design
This investigational trial, will be performed to show success of the
implantation and to collect the data about clinical performance as well as
potential unknown side effects, when BGA and BGP are used in the CERAB
configuration
A prospective, non-randomized, multi-center design is used to ensure a
representative sample of the physicians who have performed the procedure and to
provide a reasonable enrolment period for the required data to be collected.
Intervention
The procedure is an endovascular procedure that takes place in an angiochamber
after local or regional anesthesia, the aorto-iliac lesion will be reached
through the femoral arteries. An arterial sheath is introduced and guided to
the aortoiliac occluded lesion. According to the local standard of care, the
lesion is crossed with the guide wire. Once this has happened, the BeGraft
Aortic Stent Graft System will be guided to the lesion via this guide wire and
opened. Once the aortic stent is in place, a balloon is introduced and the
stent opens maximally. Next, 2 BeGraft Peripheral Stent Graft Systems are
placed distal to the BeGraft Aortic Stent Graft in the distal aorta and common
iliac aorta. Both stents are maximally opened using a balloon.
Study burden and risks
The patients eligible for the CERAB study are patients with a lesion in the
aorto-iliac arteries and are in need of treatment anyway. Regardless of their
participation in the study, they should undergo an endovascular procedure and
attend follow-up visits. The investigational devices used in this study have a
CE mark, but for a different indication than those treated in this study. For
the screening and follow-up visits, the examinations are by general standard,
except for the questionnaires: walking impairment questionnaire, EQ-5D-5L
questionnaire. The risks associated with the procedure are similar to those
associated with standard endovascular procedures. The details are described in
the protocol of the study.
Duisburger Straße 375
Oberhausen 46049
DE
Duisburger Straße 375
Oberhausen 46049
DE
Listed location countries
Age
Inclusion criteria
1.Patient has been identified with an chronic aorto-iliac occlusive lesion,
with clinical necessity for treatment.
2.The patient has been diagnosed with symptomatic peripheral artery disease,
defined by Rutherford Becker Classification score 2 to 5.
3.Patient has a projected life-expectancy of at least 24 months.
4.Patient is >=18 years old.
5.Patient is willing/capable and provides written consent to participate to the
trial and confirmed to attend the expected follow-up visits.
Angiographic inclusion criteria:
1.Patient*s anatomy is eligible for CERAB treatment, without the need for
chimneys and can be treated with a Ø 12 mm BGA.
2.The aorto-iliac lesion begins at least 1 cm below the patent renal arteries
without a need for treatment.
3.A maximum of 3 BeGraft Peripheral (Ø 7 or 8 mm) per limb in the iliac artery
can be used. In case a Ø 7 mm is used to extend, the overlapping end must be
post-dilated to ensure proper flow.
4.The target lesion has angiographic evidence of stenosis >50% or occlusion.
5.Patient*s common femoral artery and deep femoral artery are patent.
Exclusion criteria
1.Patient is currently participating in another interventional drug trial or
device trial that has not completed the entire follow up period.
2.Patient has planned any surgical intervention/procedure, that is not related
to the study procedure, within 30 days after the study procedure.
3.Patient had a Myocardial infarction or stroke within a period of 3 months
prior to the study procedure.
4.Patient had surgery (e.g. bypass surgery or stenting) in target vessels
previously.
5.Patient has an acute severe systemic infection at time of screening or in
period of 30 days prior to screening.
6.Patient has fresh thrombus at time of screening or in period of 14 days prior
to screening.
7.Patient has a CERAB procedure that is staged.
8.Female patient with childbearing potential not taking adequate contraceptives.
9.Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs
are contraindicated.
10.Patients with known hypersensitivity to the stent material (L605) and/or
PTFE.
11.Patients who are placed in an institution due to an institutional or court
order.
12.An aneurysm in the abdominal aortic and iliac segments where CERAB will be
placed is present.
13.Patient has or had aortic coarctation.
14.Patient had aortic injury/trauma related interventions previously.
15.Patient had suprarenal/visceral segment reconstructions previously.
Angiographic exclusion criteria
1.Failure of recanalization
2.A relevant accessory renal artery (>3 mm) in the infrarenal aorta is present,
that might be occluded during the procedure.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05805111 |
| CCMO | NL83883.000.23 |