A Prospective Single Arm Observational Post Market Clinical Follow Up Study to Evaluate the Safety and Performance of Mural Sirolimus - Eluting Rx PTCA Balloon Dilatation Catheter in the Real World Setting
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 4
研究概览
简要总结
Mural SEB : A prospective, single-arm, multi-centre, observational, post-market clinical follow-up study to evaluate the safety and performance of Mural Sirolimus-Eluting Rx PTCA Balloon Dilatation Catheter in the real-world setting
Device Used : Mural Sirolimus-Eluting Rx PTCA Balloon Dilatation Catheter
Objectives : The objective of this study is to assess the safety and performance of the Mural™ Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter in the real-world setting
Study Population : Mural™ Sirolimus-Eluting Rx PTCA Balloon Dilatation Catheter is indicated for the coronary native arteries. It is indicated for the dilatation of stenotic portions also including total occlusions, AMI participants and it can also be used for the post-dilatation of balloon expandable stents.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants aged Above or older to 18 years irrespective of gender with cardiovascular stenosis who will undergo an endovascular procedure require vessel dilatation.
- •Participants who require dilatation of stenotic portions also including total occlusionsand AMI participants.
- •3.The participants who require dilatation of native coronary arteries for plaque modification.
- •The Participant is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent Form in the presence of an impartial witness.
- •Participant is willing and able to comply with post-operative scheduled clinical evaluations.
排除标准
- •1.Participants with hypersensitivity or allergies to aspirin heparin clopidogrel ticlopidine bivalidurin prasugrel ticagrelor and drug such as Sirolimus (Rapamycin) or similar drugs or any analogue or derivative, hydrogenated castor oil polyvinyl pyrollidone vitamin E TPGS , Pluronic F 68 or any contrast media.
- •Participants in whom anti-platelet and or anti-coagulant therapy are contraindicated.
- •Pregnant or lactating females.
- •Participants judged to have a lesion that prevents complete inflation of an angioplasty balloon.
- •5.Transplant Participants.
- •Participants with calcified lesions requiring another type of treatment, such as Rotational Atherectomy.
- •Participants with unprotected left main coronary artery lesions.
- •The Participants with Coronary artery spasm in the absence of a significant stenosis.
- •Participants whose diseased segment cannot be pre-dilated or prepared before drug-coated balloon treatment.
- •11.Participants with unprotected lesions located in the left main coronary artery.
- •Participants under high risk of primary Percutaneous Coronary Intervention (PCI) for acute myocardial infarction characterized by presence of cardiogenic shock or evidence of massive thrombus in the infarct-related artery.
研究者
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd