CTRI/2021/03/032112已完成未知
A Real-world, prospective, observational, investigator-initiated study to evaluate the patient outcomes with Angio-SealTM femoral closure device as compared to manual compression in patients who are undergoing Percutaneous Coronary Intervention.
The Madras Medical Mission Hospital0 个研究点目标入组 90 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 90
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 scheduled to undergo PCI procedure through femoral access site route.
- •3) Acute Coronary Syndrome patients who were administered therapeutic thrombolytic agents 12 to 24 hours before PCI procedure.
- •4) In the Investigatorââ?¬•s opinion, patient is suitable for the Angio-SealTM vascular closure device or conventional hemostasis technique (manual compression) and participation in the clinical study.
- •5) 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)Pregnant or lactating women.
- •2)Patients with Systemic infection or a local infection at or near the access site.
- •3)Patients with significant anemia (hemoglobin <30%).
- •4)Patients in whom oral anticoagulation therapy cannot be stopped for the peri-procedural period or patients with INR >1.8 at the time of the procedure.
- •5)Patients with known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
- •6)Patient who have an allergy to bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel
- •7)Patients with renal insufficiency (serum creatinine >2.5 mg/dl) or on dialysis therapy
- •8)Patients who have undergone unilateral or bilateral lower extremity amputation.
- •9)Prior vascular surgery or vascular graft in region of access site.
- •10)Prior target artery closure with a vascular closure device having intravascular component 30 days prior to catheterization.
- •11)Patients with known coagulopathy, preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to artery closure
- •12)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).
- •13)Presence of any other clinically significant disease or laboratory findings that in the Investigatorââ?¬•s opinion may affect the study outcomes.
- •14)Participation in another study concurrently or within 4 weeks prior to the Screening Visit.
研究者
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