Evaluation of the Neointimal Healing by OCT of the Tapered DES Biomime Morph (TAPER-I Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- The primary endpoint is the stent coverage and neo-intimal growth assessed at six months. The neointimal healing score is based on four scaffold- or stent-related characteristics and is calculated on a lesion level:
研究概览
简要总结
The long and very long stents, although they represent a greater navigability challenge, especially in tortuous and calcified coronary arteries, they have the advantage of providing shorter procedural time, with less contrast use, less exposure to radiation, lower cost, lower risk of occlusion of lateral branches, as well as less interference in the local flow. However, in the context of the use of such long stents, as some vessels have a tapering shape, with a progressively smaller diameter in their more distal segments (as is the typical case of the left anterior descending artery), a significant disproportion (mismatch) of vessel size between the proximal and distal landing zone of the stent can be noted. Such disproportion may lead to the underestimation of the proximal reference or overestimation of the distal reference diameter of the vessel, generating an increase of the stress on the vessel wall, with consequent increase in the risk of restenosis. In view of this situation, long or very long stents were developed in a tapered shape, with progressive reduction of their diameter between their proximal and distal portion, respecting the phenomenon of tapering of the coronary artery during the treatment of very long lesions.Some of these stents also have a hybrid design, with closed cells at the ends and open cells in the middle, allowing a more efficient expansion in their middle portion (thus avoiding the dog-boning phenomenon). However, there is still a lack of studies in the literature evaluating whether these DES in a tapered shape and hybrid cells may effectively heal over time, specially with respect to strut covering and strut malapposition. Thus, this is a prospective, single-arm, open-label study, including patients presenting at least one long or very long lesion (≥ 30 mm), who will undergo angioplasty with a tapered DES. The objective is to analyze the neointimal healing as well as other data on the efficacy and safety of the tapered DES Biomime Morph in patients with long or very long lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •General clinical criteria
- •Both gender with age ≥ 18 years
- •Clinical indication for a PCI with a DES due to an acute coronary syndrome for unstable angina or non-ST elevation myocardial infarction (NSTEMI), stable angina, or in asymptomatic patients with objective evidence of ischemia.
- •Included patients must have all inclusion criteria and provide written informed consent.
- •Angiographic criteria
- •Lesions with a length ≥ 30 mm, amenable for the treatment with only one stent
- •Up to 2 "de novo" lesions/patients in native vessels
- •Vessel diameter between 2.5 and 4 mm.
排除标准
- •General clinical exclusion criteria
- •Previous use of brachytherapy or a stent in the target vessel;
- •Left ventricular ejection fraction <25%;
- •bleeding diathesis;
- •Contraindication to aspirin or P2Y12 inhibitors, heparina or any component of the DES.
- •Creatinine levels > 2.0mg/dl;
- •Leucocyte count < 3.500 céls/mm3;
- •Platelet count < 100.000 céls/mm³
- •Pregnancy;
- •Surgical procedure scheduled within the next 6 months, except if DAPT could be maintained;
- •Impossibility to provide written informed consent.
- •Angiographic Criteria
- •Left main disease > 50%;
- •Bifurcation lesions with side branch > 2.0mm in diameter where a stent should be required in the side branch (2-stent technique);
- •Occluded vessel (Thrombolysis in Myocardial Infaction grade 0 /1)
- •Restenosis;
- •Saphenous vein graft and LIMA.
结局指标
主要结局
The primary endpoint is the stent coverage and neo-intimal growth assessed at six months. The neointimal healing score is based on four scaffold- or stent-related characteristics and is calculated on a lesion level:
时间窗: Six months
1. Presence of filling defect (% intraluminal defect, ILD) is assigned a weight of "4" 2. Presence of both malapposed and uncovered struts (% malapposed/uncovered, MU) is assigned a weight of "3" 3. Presence of uncovered struts alone (% malapposed, M) is assigned a weight of "2" 4. Presence of malapposed struts alone (% uncovered, U) is assigned a weight of "1" Neointimal healing score = (%ILD \* 4)+(%MU \* 3)+(%U \* 2)+(%M \* 1).
次要结局
- Major adverse cardiac events and Stent Thrombosis(30 days, 6 months and 1 year)
- Efficacy secondary endpoints(6 months and 12 months)
研究者
Henrique Barbosa Ribeiro
Principal Investigator
University of Sao Paulo General Hospital