Coronary Disease
Conditions
Keywords
Coronary angiography (CAG), Percutaneous coronary intervention (PCI), OCT, Stent
Brief summary
Prospective, controlled, double randomized, non-blinded, multicenter, investigator initiated, academic superiority trial comparing optical coherence tomography (OCT) guided vs. angiography guided wire recrossing in jailed side branches (SB) (1. randomization 1:1)(superiority) and comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium (2. randomization 1:1) (superiority). Acute primary endpoint and 30 days clinical follow-up. Hypothesis: OCT guided wire recrossing in bifurcation stenting results in less malapposed struts in the segment facing the SB ostium. Secondary hypothesis: Treatment by Medtronic Resolute Integrity stent results in less malapposed struts at the bifurcation segment compared to treatment by the Abbott Xience Prime stent.
Detailed description
Purpose: To assess the ability of OCT to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation. To compare stent strut apposition after treatment by two different stent designs using both guiding strategies of wire recrossing.
Interventions
Sponsors
Abbott Medical Devices
Medtronic
Aarhus University Hospital Skejby
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stable or unstable angina pectoris or silent angina pectoris. * De novo coronary bifurcation lesions at LAD/diagonal, Cx/obtuse marginal, right coronary artery (RCA)- posterior descending artery (PDA)/posterolateral branch or left main (LM)/Cx/LAD. * All Medina classes except Medina 0.0.1. * Diameter of side branch ≥2.5 mm. * Diameter stenosis \>50% by operator's visual assessment * Signed informed consent
Exclusion criteria
* ST-elevation infarction within 48 hours. * Side branch lesion length \>5 mm. * Expected survival \< 1 year * Severe heart failure (NYHA≥III) * S-creatinine \>120 µmol/l. * Allergy to Contrast media, Aspirin, Clopidogrel, Ticagrelor, Ticlopidine, Everolimus or Zotarolimus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cross sectional stent strut malapposition in the main vessel bifurcation segment facing the side-branch ostium compared for optical coherence tomography and angioguided recrossing strategy | Baseline |
Secondary
| Measure | Time frame |
|---|---|
| Procedural: 2. Procedure duration (sheath insertion to closure device excluding treatment of other vessels) | Baseline |
| Procedural: 3. Contrast use | Baseline |
| Procedural: 4. Fluoroscopy time | Baseline |
| Optical coherence tomography endpoints: 5. Malapposition in the main vessel segment limited by and facing the side-branch ostium compared for stent type (second randomization) | Baseline |
| Optical coherence tomography endpoints: Malapposition in the proximal and distal main vessel segments and in the quadrants opposite to the side branch origin for stent type and recross strategy | Baseline |
| Optical coherence tomography endpoints: Distance between malapposed strut and vessel wall in all segments for stent type and recross strategy | Baseline |
| Procedural: 1. Success in recrossing into designated strut hole when visible and indicated | Baseline |
| Optical coherence tomography endpoints: Ostial stent area stenosis by optical coherence tomography (side branch reference area by 3D QCA) | Baseline |
| Angiographic endpoints: Segmental assessment; Proximal edge, proximal main vessel, bifurcation segment, distal main vessel, distal edge, ostial 5 mm of side branch. Pre and post side branch intervention | Baseline |
| Ostial side branch area stenosis | Baseline |
| Ostial side branch acute gain after main vessel (MV) stenting | Baseline |
| Minimal luminal area of all segments | Baseline |
| Angiographic area stenosis of all other segments | Baseline |
| Optical coherence tomography endpoints: Minimum expansion of the stents expressed as absolute area and percentage of the closest reference area, for stent type and recross strategy | Baseline |
Countries
Belgium, Denmark, United Kingdom
Contacts
Primary ContactNiels R Holm, MD
Backup ContactEvald H Christiansen, MD
Outcome results
None listed