The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study

Conditions
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Coronary Disease

Intervention / Treatment
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* Device: Xience Prime Stent
* Device: Medtronic Resolute Integrity stent
* Procedure: Angiography
* Procedure: OCT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medtronic Resolute Integrity stent<br>Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium | Procedure: Angiography<br> <br> * Other names: CAG;Procedure: OCT<br> <br> |
| Experimental: OCT<br>OCT to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation. | Device: Xience Prime Stent<br> <br> * Other names: Stent;Device: Medtronic Resolute Integrity stent<br> <br> * Other names: Stent;|
| Active Comparator: Angiography<br>Angiography to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation. | Device: Xience Prime Stent<br> <br> * Other names: Stent;Device: Medtronic Resolute Integrity stent<br> <br> * Other names: Stent;|
| Active Comparator: Xience Prime stent<br>Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium | Procedure: Angiography<br> <br> * Other names: CAG;Procedure: OCT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stent, Coronary angiography (CAG), Percutaneous coronary intervention (PCI), OCT