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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medtronic Resolute Integrity stent | Experimental | Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium |
|
| OCT | Experimental | OCT to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation. |
|
| Angiography | Active Comparator | Angiography to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation. |
|
| Xience Prime stent | Active Comparator | Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xience Prime Stent | Device |
|
| |
| Medtronic Resolute Integrity stent |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural: 1. Success in recrossing into designated strut hole when visible and indicated | Baseline | |
| Procedural: 2. Procedure duration (sheath insertion to closure device excluding treatment of other vessels) | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Niels R Holm, MD | Contact | +45 7845 0000 | 52254 | niels.holm@ki.au.dk |
| Evald H Christiansen, MD | Contact | +45 7845 0000 | 52028 | hellbarg@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Niels R Holm, MD | Aarhus University Hospital Skejby | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Recruiting | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D015607 | Stents |
| D002533 | Cerebral Angiography |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
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| Device |
|
|
| Angiography | Procedure |
|
|
| OCT | Procedure |
|
| 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 |
| 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 |
| 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 |
| Aarhus University Hspital | Recruiting | Aarhus N | 8200 | Denmark |
|
| Royal Brompton Hospital | Recruiting | London | United Kingdom |
|
| D003952 |
| Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000792 | Angiography |
| D011859 | Radiography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |