The primary objective of the ABSORB EXTEND trial is to continue the assessment of the safety and performance of the BVS EECSS Gen 1.1 in a population of up to 1,000 subjects with a maximum of two de novo native coronary artery lesions each located…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Acute success (clinical device and clinical procedure);
Cardiac Death at 30, 180 days, and 1, 2, and 3 years;
Myocardial Infarction at 30, 180 days, and 1, 2, and 3 years;
Target Vessel Myocardial Infarction at 30, 180 days, and 1, 2, and 3 years;
Ischemia Driven MACE at 30, 180 days, and 1, 2, and 3 years;
Ischemia driven Target Vessel Failure at 30, 180 days, and 1, 2, and 3 years;
Ischemia Driven Target Lesion Revascularization at 30, 180 days and 1, 2, and 3
years;
Ischemia Driven Target Vessel Revascularization at 30, 180 days and 1, 2, and 3
years;
Stent thrombosis at 30, 180 days, and 1, 2, and 3 years.
Secondary outcome
Descriptive analysis of strut, lesion and vessel morphology post-procedure and
at 2 years;
Lumen area post-procedure and at 2 years;
Minimum luminal area (MLA) post-procedure and at 2 years;
In-stent Late Loss (LL) at 2 years;
In-segment LL at 2 years;
Proximal LL (proximal defined as within 5 mm of tissue proximal to stent
placement) at 2 years;
Distal LL (distal defined as within 5 mm of tissue distal to stent placement)
at 2 years;
In-stent and in-segment Minimum Luminal Diameter (MLD) post-procedure and at 2
years;
In-stent and in-segment % Diameter Stenosis (DS) post-procedure and at 2 years;
In-stent and in-segment Angiographic Binary Restenosis (ABR) rate at 2 years;
Aneurysm, thrombus, persisting dissection at 2 years;
Vessel area post-procedure and at 2 years;
In-stent %Volume Obstruction (VO) at 2 years.
Background summary
The ABSORB EXTEND Clinical Investigation Plan 09-386 (version 2.0, 15 March,
2010) is a continuation in the assessment of safety and performance of the BVS
Everolimus Eluting Coronary Stent System (BVS EECSS) in the treatment of
subjects with a maximum of two de novo native coronary artery lesions located
in two different major epicardial vessels. The ABSORB EXTEND trial is intended
to expand the treatment to a larger subject population to receive the BVS
EECSS, following the completion of enrollment of 110 subjects in the ongoing
First in Man ABSORB Clinical Investigation (ABSORB), including subjects with
longer lesions.
Subjects enrolled in ABSORB EXTEND will receive the BVS EECSS Gen 1.1 scaffold.
This scaffold is currently under evaluation in the approximately 80 subjects
who are planned to be enrolled in Cohort B of ABSORB, which was initiated on
March 19, 2009, and is currently enrolling. The BVS EECSS Gen 1.1 is similar to
the BVS EECSS Gen 1.0 that was evaluated in the first 30 subjects who compose
Cohort A of ABSORB.
Study objective
The primary objective of the ABSORB EXTEND trial is to continue the assessment
of the safety and performance of the BVS EECSS Gen 1.1 in a population of up to
1,000 subjects with a maximum of two de novo native coronary artery lesions
each located in different epicardial vessels. The ABSORB EXTEND trial is
intended to expand the treatment to subjects with longer lesions than those in
the ABSORB trial.
Study design
Prospective, single-arm, open-labeled clinical investigation
Intervention
Placement of the scaffold study will not differ from a routine stent procedure
(other than the use of a non-CE marked stent). Post-placement of the scaffold
includes IVUS and OCT (this is optional, but it is to be expected that the
Erasmus MC will participate in this substudy). Apart from a telephone follow-up
(or outpatients), a MSCT will be done after 18 months and 2 years after the
initial procedure a repeat angio, including IVUS and OCT will be performed.
Study burden and risks
The potential risks do not differ from the risks associated with routine stent
procedures as described in the brochure of the Dutch Heart Foundation.
Death-0.2-0.5%
Myocardial infarction during the intervention
Hematoma (groin/ arterial sheath)
Major bleeding caused by the administration of anticoagulants during and after
treatment
In addition to this, is it important to note that patients undergo during the
follow-up phase a repeat angio. The risk of this repeat angio is also mentioned
in the brochure of the Heart Foundation.
Park Lane, Culliganlaan 2B
Diegem 1831
BE
Park Lane, Culliganlaan 2B
Diegem 1831
BE
Listed location countries
Age
Inclusion criteria
-) =< 2 de novo lesions can be treated, each located in a separate native epicardial vessel.
-) Target lesion(s) must measure <= 28 mm in length.
-) Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and < 100% with a TIMI flow of >= 1.
-) Percutaneous interventions for lesions in a non-target vessel are allowed if done >= 30 days prior to or if planned to be done 6 months after the index procedure.
Exclusion criteria
-) Lesion(s) located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.
-) Lesion(s) involving a bifurcation with side branch vessel >= 2 mm in diameter, ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation.
-) Total occlusion (TIMI flow 0), prior to wire passing.
-) Target vessel(s) contains visible thrombus.
-) Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s).
-) Subject has received brachytherapy in any epicardial vessel (including side branches).
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 |
|---|---|
| CCMO | NL30435.078.09 |