coronary artery disase. myocardial infarction
Conditions
Interventions
Randomization between Xience metallic stent and bioresorbable scaffold
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) History of chest pain 18 years 5) Oral informed consent
Exclusion criteria
Exclusion criteria: 1) Contraindications to long term DAPT 2) Known kidney failure with GFR 2,5 mm) at culprit lesion. 2) TIMI 0-1 flow after aspiration 3) Unable to advance thrombus aspiration catheter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimum flow area by OCT after 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| OCT endpoints 1. Area stenosis 2. Lumen late loss 3. Crushed stent segments 4. Malapposition of stent struts 5. Minimum expansion of the stents expressed as absolute area and percentage of the closest reference area, 6. Vessel ostial stent area (acute and at FU) 7. Thrombus burden Angiographic endpoints 1.TIMI flow pre and post PCI, 2.Blush grade 3.Thrombus burden 4. Angiographic complications 5. Contrast use 6. Procedure time 7. Radiation skin dose Clinical endpoints Index admission: 1. Total death 2. Cardiac death 3. Non-index procedure myocardial infarction 4. Stent thrombosis (definite and probable) 5. TLR and TVR 6. non-TVR Follow up: 1. Total death 2. Cardiac death 3. Non-index procedure myocardial infarction 4. Stent thrombosis (definite and probarble) 5. TLR and TVR 6. non-TVR 7. CCS angina class 8. Vascular cerebral events 9. Admissions for congestive heart failure or arrhythmia | — |
Countries
Netherlands
Outcome results
None listed