NL-OMON53537尚未招募不适用
Impella®-Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and Reduced Left Ventricular Function: The PROTECT IV Trial - The PROTECT IV Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
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
- •Inclusion Criteria:
- •Subjects must meet all of the following Inclusion Criteria to participate in
- •1. Age >=18 years and <=90 years
- •2. Clinical presentation and baseline left ventricular function are as follows:
- •Either 2A or 2B must be present
- •A. Subject has CCS or NSTEMI with an LVEF <=40%
- •NOTE: The LVEF must be quantitatively measured as <=40% by echo within 30 days
- •assuming no change in clinical condition. If multiple echos have been performed
- •within 30 days, the most recent test must be used to qualify the patient. NOTE:
- •Subject qualifies if the quantitative site read LVEF is <=30%; if the
- •quantitative read is >30% - <=40% the Echo Core Lab must confirm the LVEF is
- •<=40% before subject enrollment (Core Lab will provide <48-hour turnaround).
- •Similarly, if the site read is qualitative only (i.e., only provides broad
- •ranges without detailed LVEF quantification), the Echo Core Lab must confirm
- •the LVEF is <=40% before subject enrollment.
- •B. Subject has STEMI >=24 hours and <30 days after symptom onset with an LVEF
- •NOTE: In patients qualifying with recent STEMI, the LVEF must be demonstrated
- •to be <=30%quantitative echocardiography after the primary PCI procedure (if
- •performed) and within 72- hours prior to the planned randomization. If primary
- •PCI was not performed, the qualifying echocardiogram will be the one taken
- •during the index hospitalization closest to the index procedure. If the site
- •read is qualitative only (i.e., only provides broad ranges without detailed
- •LVEF quantification), the Echo Core Lab must confirm the LVEF is <=30% before
- •subject enrollment.
- •3. Local heart team (interventional cardiologist and cardiac surgeon) has
- •determined that PCI is indicated and is the most appropriate management for the
- •4. Complex PCI will be performed: Either 4A or 4B must be met
- •A. One of the following must be present:
- •i. Triple vessel disease is present (visually-assessed angiographic DS >=80% [or
- •>=40% if non-invasive evidence of ischemia on a localizing stress test or
- •invasive evidence of ischemia (FFR <=0.80 or iFR <=0.89)] is present in all 3
- •epicardial coronary artery distributions in a main vessel or branch with
- •visually-assessed reference vessel diameter
- •>=2.5 mm) with PCI planned in >=2 of these vessels in the proximal or mid LAD,
- •proximal or mid-LCX or proximal, mid- or distal RCA [i.e., not a branch vessel])
- •ii. Left main distal bifurcation or trifurcation disease (visually- assessed DS
- •>=50% [or DS >=30% if non-invasive evidence of ischemia in both the anterior and
- •posterolateral distributions or left main IVUS MLA <=6.0 mm2 or FFR
- •<=0.80 or iFR <=0.89] is present) with planned intervention of the left main plus
- •at least 2 branch vessels (i.e., the ostial LAD, ostial LCX or ostial ramus)
- •iii. Left main equivalent disease with both ostial LAD and ostial LCX having
- •visually-assessed angiographic DS
- •>=80% [or >=40% if non-invasive evidence of ischemia on a localizing stress test
- •or invasive evidence of ischemia (FFR <=0.80 or iFR <=0.89] and requiring
- •intervention in both branches
- •iv. Intervention of the last remaining vessel (native coronary artery or bypass
- •B. Multivessel disease is present (visually-assessed angiographic DS >=80% [or
- •>=40% if non-invasive or invasive eviden
排除标准
- •Exclusion Criteria:
- •Subjects must NOT meet any of the following Exclusion Criteria to participate
- •in the Trial
- •1. STEMI <=24 hours from the onset of ischemic symptoms or at any time if
- •mechanical complications of transmural infarction are present (e.g., VSD,
- •papillary muscle rupture, etc.)
- •2. Cardiogenic shock (SBP <80 mmHg for >=30 mins and not responsive to
- •intravenous fluids or hemodynamic deterioration for any duration requiring
- •pressors or mechanical circulatory support, including IABP)
- •3. Subject is presently or recently intubated for the current admission (NOTE:
- •recently intubated patients must be extubated for >24 hours with full
- •neurologic recovery)
- •4. Cardiorespiratory arrest related to the current admission unless subject is
- •extubated for >24 hours with full neurologic recovery and hemodynamically stable
- •5. Any contraindication or inability to Impella placement in both the left and
- •right common femoral artery based on clinical or imaging findings, including
- •iliofemoral artery diameter <5 mm, tortuous vascular anatomy or severe
- •bilateral peripheral vascular disease of the iliac or femoral arteries that
- •can*t be adequately treated (e.g., with intravascular lithotripsy)
- •a. Computed tomography (CT), magnetic resonance angiography (MRA) or contrast
- •angiography to assess the aorta and iliofemoral vasculature to ensure Impella
- •compatibility must be performed within 90 days prior to randomization. It is
- •recommended that this evaluation be performed prior to the index procedure.
- •Absent a qualifying pre-procedure imaging study, contrast angiography of the
- •potential Impella access vessel(s) must be performed in the Cath Lab before the
- •planned enrollment after which the subject may be randomized if he/she still
- •qualifies. Of note, if pre-procedure imaging was performed and after this test
- •but before randomization there was a worsening in PVD symptoms, repeat imaging
- •must be performed prior to randomization.
- •b. If iliofemoral peripheral vascular disease is present precluding Impella use
- •that can be adequately treated with angioplasty, atherectomy or lithotripsy
- •(without a stent), the subject can be enrolled if such treatment is undertaken
- •and is successful and uncomplicated - randomization must not be performed until
- •such successful and uncomplicated treatment.
- •6. Iliofemoral stents placed within 6 months of enrollment with planned
- •vascular access through these vascular segments
- •7. Vascular access for Impella is required in any location other than the left
- •or right common femoral artery (i.e., axillary access, transcaval access, etc.,
- •for Impella access are not permitted)
- •8. Known left ventricular thrombus
- •9. Incessant ventricular arrhythmias that would likely preclude stable Impella
- •positioning
- •10. Severe aortic stenosis or severe aortic insufficiency
- •11. Prior mechanical valve or self-expanding TAVR (NOTE: prior bioprosthetic
- •surgical valve or balloon expandable TAVR implanted >24 hours pre-procedure is
- •acceptable)
- •12. Prior CABG within three (3) months or successful prior PCI of at least one
- •(1) attempted lesion within 12 months (including during the index
- •hospitalization prior to randomization), that has not experienced stent
- •thrombosis or restenosis during that 12-month period; the one (1) exception is
- 另有 1 项未显示
研究者
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