The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Diameter of side branch ≥2.5 mm.
- •Diameter stenosis >50% by operator's visual assessment
- •Signed informed consent
排除标准
- •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.
结局指标
主要结局
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
时间窗: Baseline
次要结局
- Procedural: 1. Success in recrossing into designated strut hole when visible and indicated(Baseline)
- Optical coherence tomography endpoints: Distance between malapposed strut and vessel wall in all segments for stent type and recross strategy(Baseline)
- Procedural: 2. Procedure duration (sheath insertion to closure device excluding treatment of other vessels)(Baseline)
- Procedural: 3. Contrast use(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: 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: 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: Ostial stent area stenosis by optical coherence tomography (side branch reference area by 3D QCA)(Baseline)
- Minimal luminal area of all segments(Baseline)
- Angiographic area stenosis of all other segments(Baseline)
- Procedural: 4. Fluoroscopy time(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)
研究者
Niels Ramsing Holm
MD
Aarhus University Hospital Skejby