An interventional study of Xience Prime Stent and Medtronic Resolute Integrity stent in Coronary Disease, sponsored by Aarhus University Hospital Skejby. Status unknown at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-06.
Sponsored by Aarhus University Hospital Skejby · Not applicable, Interventional, and Treatment
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.
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.
2,839 studies on the registry are indexed under Coronary Disease; 311 are open to participants now.
This study's planned enrollment of 60 is below the median of 124 across 1,583 interventional studies indexed under Coronary Disease.
Browse Coronary Disease studies →Aarhus University Hospital Skejby is the lead sponsor of 59 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium
Procedure: Angiography · Procedure: OCT
OCT to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.
Device: Xience Prime Stent · Device: Medtronic Resolute Integrity stent
Angiography to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.
Device: Xience Prime Stent · Device: Medtronic Resolute Integrity stent
Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium
Procedure: Angiography · Procedure: OCT
Also known as: Stent
Also known as: Stent
Also known as: CAG
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
Time frame: Baseline
Procedural: 1. Success in recrossing into designated strut hole when visible and indicated
Time frame: Baseline
Procedural: 2. Procedure duration (sheath insertion to closure device excluding treatment of other vessels)
Time frame: Baseline
Procedural: 3. Contrast use
Time frame: Baseline
Procedural: 4. Fluoroscopy time
Time frame: 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)
Time frame: 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
Time frame: Baseline
Optical coherence tomography endpoints: Distance between malapposed strut and vessel wall in all segments for stent type and recross strategy
Time frame: 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
Time frame: Baseline
Optical coherence tomography endpoints: Ostial stent area stenosis by optical coherence tomography (side branch reference area by 3D QCA)
Time frame: 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
Time frame: Baseline
Ostial side branch area stenosis
Time frame: Baseline
Ostial side branch acute gain after main vessel (MV) stenting
Time frame: Baseline
Minimal luminal area of all segments
Time frame: Baseline
Angiographic area stenosis of all other segments
Time frame: Baseline
This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Aarhus University Hospital Skejby