To compare the endothelium-dependent and non-endothelium-dependent vasomotion and perfusion restoration in coronary vessels treated with ABSORB BVS or Xience DES in CTO coronary lesions
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The endothelium-dependent and non-endothelium-dependent vasomotion and
perfusion restoration in coronary vessels treated with ABSORB BVS or Xience DES
in CTO coronary lesions
Secondary outcome
o To compare the extent of pharmacologically induced vasomotion responses of
vessels treated with a metallic stent or a bioresorbable vascular scaffold in
the treated segment and a normal vessel segment distal to the stented segment
o To evaluate the long-term physiological vascular responses of vessels treated
with a metallic stent or with a bioresorbable vascular scaffold in the treated
segment and a normal vessel segment distal to the stented segment
o To evaluate the difference in microvascular function between resting and
hyperemic conditions at follow-up after CTO revascularization, and the
differences between ABSORB BVS or Xience DES implantation.
o To evaluate the differences in total coronary conductance between vessels
treated with ABSORB BVS or Xience DES implantation.
o To evaluate how these parameters and changes relate to the a priori extent of
collateralization
o To assess the recruitment of collaterals at baseline and after 36-month and
the effect of treatment strategy on this recruitment
o To determine the time to ST-shift during balloon occlusion in the treated CTO
lesion at baseline and at 36-month
Background summary
The ABSORB bioresorbable vascular scaffold (BVS; Abbott Vascular, Santa Clara,
CA, USA) has been designed with the aim to provide temporary vessel scaffolding
and subsequent bioresorption of scaffold material. Thereby, in contrast with
permanent caging of the coronary artery by means of metallic stent platforms,
mechanical revascularization with ABSORB BVS would allow restoration of
vascular responses to shear stress and physiological and
pharmacologically-induced vasomotion over time, akin to a non-stented coronary
segments.
Basic vasomotor testing of vessel segments treated with BVS in the ABSORBTM
Everolimus Eluting Bioresorbable Vascular Scaffold (ABSORB BVS) strategy Cohort
A and B, using quantitative coronary angiography analysis to assess the
pharmacologically-induced vasomotion of the stented coronary segments,
indicated that normal vascular responses are progressively restored from 12 to
24 months after implantation of the ABSORB BVS. However, these physiological
characteristics of ABSORB BVS placement have only been evaluated in 1) coronary
lesions with relatively low complexity, 2) using a single-arm study design
evaluating BVS only, and 3) using basic quantitative coronary angiography
instead of advanced coronary physiological measures.
The Amsterdam Investigator-intiateD ABSORB all-comers trial (AIDA) is a
prospective, randomized (1:1) evaluation of the ABSORB BVS with the XIENCE
family everolimus-eluting stents in an all-comer population undergoing PCI. The
AIDA trial thereby provides a unique platform to study the restoration of
vascular physiology between BVS and the contemporary standard of metallic
stents.
Data on the use of the ABSORB BVS in CTO lesion are sparse. A study of
Vaquerizo et al. (7) demonstrated the feasibility, safety and short-term
efficacy of PCI for CTO lesions with the Absorb BVS. The use of the Absorb BVS
might prove to be useful, especially
in long segments of disease, to avoid *full metal jackets* and the potential
benefit of a restored functional endothelium.
Study objective
To compare the endothelium-dependent and non-endothelium-dependent vasomotion
and perfusion restoration in coronary vessels treated with ABSORB BVS or Xience
DES in CTO coronary lesions
Study design
A prospective, randomized (1:1) evaluation of the physiological characteristics
of ABSORB tm everolimus eluting bioresorbable vascular scaffold strategy versus
the XIENCE family (XIENCE PRIMEtm or XIENCE Xpeditiontm) everolimus eluting
coronary stent system in the treatment of chronic total occluded coronary (CTO)
lesions.
Intervention
Index strategy:
Abbott Vascular ABSORBTM Everolimus Eluting Bioresorbable Vascular Scaffold
strategy (referred to hereafter as ABSORB BVS)
Control strategy:
Abbott Vascular XIENCE PRIMETM or Abbott Vascular XIENCE Xpeditiontm Everolimus
Eluting coronary stent systems (referred to hereafter as XIENCE family)
Study burden and risks
The additional risk of complications from using the Combowire is very low.
There is a small change that the ComboWire will cause a dissection, 1 at 1000
patients. Usually this will heal by itself without further invasive actions,
sometimes another stent needs to be placed to close this dissection. The risk
of death, cerebrovascular accident or myocardial infarction is expected to be
similar to an angiography without intravascular pressure-flow measurements.
During the intracoronary measurements acetylcholin, nitroglycerin and adenosin
will be administered. The risk of these medications is very low, but sometimes
patients can experience flushig, dyspnea or passing chest pain that usually
disapears quickly after stop of medication infusion.
Furthermore patients will be asked to undergo an extra angiography after 3
years with additional intracoronairy measurements, this is an extra burden for
the patient. After this follow-up, there are no additional visits or examines
for this substudy.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
o Subject is enrolled in the Amsterdam Investigator-InitiateD Absorb strategy trial
o Subject has a chronic total occlusion
o Subject must agree to undergo all clinical investigation plan-required follow-up visits and to undergo follow-up angiography and intracoronary measurements
o Subject is able to verbally confirm understanding and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.
Exclusion criteria
o Subject is younger than 18 years of age
o Subject has known hypersensitivity or contraindication to Acetylcholine, nitroglycerin, adenosine or contrast that cannot be adequately pre-medicated.
o Known renal insufficiency (eg. estimated Glomerular Filtration Rate (eGFR) <60mL/min/1.73m2 or serum creatinine level of >2.5mg/dL or subject on dialysis)
o Subject is belonging to a vulnerable population (per investigator*s judgment, e.g., subordinate hospital staff) or subject unable to read or write.
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 | NL52362.018.15 |