coronary artery disease coronary artherosclerosis
Conditions
Interventions
Index strategy:
Abbott Vascular ABSORBTM Everolimus Eluting Bioresorbable Vascular Scaffold
strategy (referred to hereafter as ABSORB BVS)
Control strategy:
Abbott Vascular XIENCE PRIMETM or Abbot
Physiology
Xience drug-eluting stent
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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) 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
The Netherlands
Outcome results
None listed