CTRI/2009/091/000425已完成4 期
PROTECT (Patient Related OuTcomes with Endeavor versus Cypher stenting Trial) is a prospective, multicenter, randomized, two-arm, open-label trial designed to evaluate whether the Endeavor stent Protects against late stent thrombosis resulting in less deaths and myocardial infarctions - PROTECT
Medtronic Vascular0 个研究点目标入组 8,800 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8,800
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
入选标准
- •1. Patient is > 18 years of age (or minimum age as required by local regulations).
- •2. The patient has consented to participate and has authorized the collection and release of his
- •medical information by signing the ?Patient Informed Consent Form?.
- •3. All lesions requiring interventions (target lesions - one to a maximum of four) in one or
- •more native coronary arteries are amendable for implantation of one or more Endeavor®
- •Zotarolimus Eluting Coronary Stent System or Cypher® Sirolimus-eluting Coronary
- •4. Patient indication, lesion length and vessel diameter of the target lesion(s) are according to
- •the ?Indications for Use? as mentioned in the ?Instructions for Use? that comes with every
- •Endeavor® Zotarolimus Eluting Coronary Stent System and Cypher® Sirolimus-eluting
- •Coronary Stent. Patients should qualify for both systems before randomization.
- •5. The patient is willing and able to cooperate with study procedures and required follow up
排除标准
- •1. Women with known pregnancy or who are lactating.
- •2. Planned elective surgery necessitating discontinuation of clopidogrel within the regular
- •planned period of clopidogrel administration.
- •3. Patients expected not to be compliant with the anti-platelet and/or anticoagulation therapy
- •4. Previous brachy-therapy.
- •5. Previous implantation of a drug eluting stent.
- •6. Previous implantation of a bare metal stent in the preceding year.
- •7. Simultaneous or planned intervention other non cardiac vessels including but not limited to
- •renal artery or carotid artery.
- •8. Current medical condition with a life expectancy of less than 3 years.
- •9. Manifest acute severe heart failure (Killip class III-IV).
- •10. The patient is currently, and during the first 3 years of the PROTECT trial, participating in
- •another investigational device or drug study that clinically interferes with the PROTECTstudy
- •endpoints; or requires coronary angiography or other coronary artery imaging
- •procedures. The patient may only be enrolled in the PROTECT-study once.
- •11. Patients with medical conditions that preclude the follow-up as defined in the protocol or
- •that otherwise limits participation in this study.
- •12. Patients on warfarin or similar anti-coagulant therapy.
- •13. Patients with hypersensitivity or allergies to one of the drugs or components indicated in the
- •Instructions for Use of either stents.
- •14. Patients who are judged to have a lesion that prevents complete inflation of an angioplasty
- •15. Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.
- •16. Transplant patients.
研究者
相似试验
进行中（未招募）
1 期
ong-term follow-up of the WAS gene therapy studyWiskott-Aldrich syndrome (WAS) is a rare X-linked immunodeficiencycaused by mutations in a single gene ,the Wiskott-Aldrich SyndromeProtein (WASP). WAS is characterised by micro-thrombocytopenia,recurrent infections,eczema and associated with a high incidence ofauto-immunity and of lymphoid malignancies. Over 150 uniquemutations in the WAS gene have been identified.Loss-of-functionmutations in this gene have widespread consequences on hematopoieticlineages.MedDRA version: 19.1Level: PTClassification code 10047992Term: Wiskott-Aldrich syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2014-000274-20-GBGenethon10
已完成
不适用
RISK STRATIFICATION OF PATIENTS PRESENTING WITH UPPER GASTROINTESTINAL BLEEDING TOTHE EMERGENCY DEPARTMENTCTRI/2019/03/018127Jubilee Centre for Medical Research348
尚未招募
不适用
PROTEGO: PRospective Observational cohort Trial Evaluating correlation of clinical findings, symptoms and disease development of German in- or Outpatients infected with SARS-CoV-2 - a CHIR-Net Student-Initiated German Medical Audit trial COVID-19 study (CHIR-Net SIGMA study group)DRKS00021226niversitätsklinikum Heidelberg500
招募中
1 期
tDCS study for TBISevere traumatic brain injurytraumatic brain injury, subdural hematoma, diffuse brain injuryD000070642, D006408, D000070625JPRN-jRCTs032200263Higuchi Yoshinori6
进行中（未招募）
不适用
PROMISE: Patient Reported Outcome Measures in cancer care: a hybrid effectiveness-Implementation trial to optimise Symptom control and health service ExperienceCancerACTRN12620001290987QIMR Berghofer Medical Research Institute600