NL-OMON54574招募中不适用
A Prospective Randomized single blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR* 014 Drug Eluting Balloon in the Treatment of Subjects with In-stent Restenosis - Selution SLR014 ISR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects must meet all of the following clinical criteria to participate in the
- •1. Subject age is >= 18 years or minimum legal age as required by local
- •regulations.
- •2. Female subjects of childbearing potential have a negative pregnancy test <= 7
- •days before
- •the procedure.
- •3. Subject presents with chronic coronary syndrome (CCS) (manifest as
- •documented angina or positive functional testing), unstable angina or
- •stabilized non-ST elevation MI (NSTEMI) (biomarkers stabilized or down
- •trending) with an indication for PCI and planned intervention.
- •4. Subject is eligible for DAPT treatment with aspirin plus either,
- •Clopidogrel, Prasugrel, or Ticagrelor. Note: Subjects who require continued
- •oral anticoagulant therapy may omit aspirin at discretion of investigator.
- •5. Life expectancy > 1 year in opinion of investigator.
- •6. Subject is willing and able to provide informed consent and comply with
- •study procedures and required follow-up evaluations.
- •Subjects must meet all the following imaging criteria to participate in the
- •1. Target lesion is within a native coronary artery or major branch.
- •2. Target lesion is within a previously placed BMS or DES and does not extend
- •further than 5 mm beyond either the proximal or distal edge of the stent.
- •3. Up to two (2) non-target lesions in non-target vessels may be treated, but
- •successful PCI of the non-target lesions must be completed before treatment of
- •the target lesion. Successful treatment is defined as no greater than 30%
- •residual stenosis by visual estimate, no dissection greater than National
- •Heart, Lung, Blood Institute (NHLBI) type C, and Thrombolysis in Myocardial
- •Infarction (TIMI) grade flow in the non-target lesion > 2.
- •4. Target lesion is < 26 mm in length.
- •5. Target lesion has diameter stenosis > 50% and <= 99% by visual estimate.
- •6. RVD is >= 2.00 mm and <= 4.50 mm.
- •7. Target lesion must be successfully pre-dilated/pre-treated. Note: Successful
- •pre-dilation/pre-treatment is defined as dilation or pre-treatment that
- •achieves stent expansion of approximately 80% of the distal RVD (at the
- •discretion of the investigator) based on intravascular ultrasound
- •(IVUS)/optical coherence tomography (OCT) and no greater than 30% residual
- •stenosis by visual estimate and no dissection greater than NHLBI type C. TIMI
- •grade flow in the target lesion must be > 2. Note: Atherectomy and cutting
- •balloon are permitted for pre-treatment.
排除标准
- •Clinical exclusion criteria:
- •1.Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents
- •required for the procedure.
- •2. STEMI within 30 days.
- •3. Planned treatment of additional lesions in the target vessel, or more than
- •two (2) non-target lesions within non-target vessels, during the index
- •4. Target lesion is located within a bifurcation with planned treatment of side
- •branch vessel.
- •5. Target lesion is the more than 3rd or greater stent failure (i.e., more than
- •two [2] layers of
- •stent are present at any segment of the target lesion).
- •6. Target vessel had any previous vascular brachytherapy treatment or is
- •planned to undergo brachytherapy at index procedure.
- •7. Previous PCI of the target vessel within 30 days.
- •8. Planned PCI of a non-target vessel, or a non-target lesion in the target
- •vessel, within 30 days of randomization.
- •9. Subject has chronic renal insufficiency (dialysis dependent, or glomerular
- •filtration rate [GFR] <= 30 ml/min/1.73 m2 within 30 days of index procedure) or
- •has undergone renal transplantation.
- •10. Subject has acute renal insufficiency confirmed by 50% increase of serum
- •creatinine within 48 hours before procedure and/or decrease in urine output.
- •11. History of active peptic ulcer or gastrointestinal bleeding within prior 6
- •months or other inability to comply with the recommended duration of DAPT.
- •12. Subject is pregnant, breast-feeding, or a woman of childbearing potential
- •who is not using appropriate contraceptives to avoid becoming pregnant.
- •13. Documented left ventricular ejection fraction (LVEF) < 25%.
- •14. Currently participating in another investigational drug or device study
- •that has not completed primary endpoint follow-up.
- •Imaging exclusion criteria:
- •1. Target lesion is total occlusion or has evidence of thrombus.
- •2. Target lesion involves an unprotected left main.
- •3. Target lesion has > 30% residual stenosis by visual estimate or dissection
- •greater than NHLBI type C after pre-dilation/pre-treatment.
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