CTRI/2021/06/034102招募中未知
A Real-world, prospective, multicentre, observational, investigator-initiated study to evaluate the outcomes in patients undergoing percutaneous coronary intervention (PCI) with Crush technique as compared to Culotte technique for coronary bifurcation lesions. - REVALUATIO
Dr Shuvanan Ray0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Patients meeting with following criteria to be included in the study:
- •1. Patients aged 18 years and above of both gender.
- •2. Patients diagnosed with de novo coronary
- •true bifurcation lesion.
- •3. Patients scheduled to undergo PCI procedure with Crush or Culotte technique utilizing sirolimus eluting stent.
- •4. Patients with medina classification of
- •bifurcation lesions 1.1.1, 0.1.1 or 1.0.1.
- •5. Patients who are able to administer Dual
- •Antiplatelet Therapy for a period of more than 1
- •year after PCI procedure.
- •6. Patients who are having proximal vessel
- •size of ââ?°Â¥ 3mm and side branch vessel size of ââ?°Â¥
- •7. Patients with Calcified Plaque in the target vessel for PCI procedure can be included at Investigatorââ?¬•s discretion at study site.
- •8. Patient or Legally acceptable representative
- •of patient willing to sign an Informed
- •Consent Form indicating that they
- •understand the purpose of and the procedures
- •required for the trial and are willing to
- •participate in the study.
排除标准
- •Patients meeting with following criteria to be excluded from the study:
- •1. Patients who have experienced acute myocardial
- •infarction(STEMI) within 24 hours.
- •2. Patients with thrombus containing lesion.
- •3. Patients with triple vessel disease.
- •4. Patients with SYNTAX score > 23.
- •5. Patients who underwent prior coronary artery
- •bypass grafting
- •6. Patients with known liver or kidney dysfunction (eGFR <60)
- •7. Patients with left ventricular ejection fraction ââ?°Â¤30%.
- •8. Patients with life expectancy of less than 1
- •9. Patients who are suspected of or
- •known to have an intolerance to sirolimus.
- •10. Patients who are infected with COVID-19
- •at the time of enrolment as determined by the
- •standard COVID-19 infection screening protocols
- •followed by the clinical study site
- •(hospital).
- •11. Presence of any other clinically
- •significant disease or laboratory findings
- •that in the Investigatorââ?¬•s opinion may
- •affect the study outcomes.
- •12. Participation in another study concurrently
- •or within 4 weeks prior to the Screening Visit.
研究者
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