Micro-axial Flow Pump-Supported PCI in Complex Coronary Artery Disease With Ischemic LV Dysfunction (PIVOT)
2026年6月28日 更新者:China National Center for Cardiovascular Diseases
Micro-axial Flow Pump-Supported PCI Plus Optimal Medical Therapy Versus Optimal Medical Therapy Alone in Complex Coronary Artery Disease With Ischemic LV Dysfunction: A Prospective, Multicenter, Randomized Controlled Trial
Based on a multi-center randomized controlled study, this research aims to evaluate the efficacy and safety of interventional therapy supported by the CorVad percutaneous left ventricular assist system (Micro-axial Flow Pump) for patients with complex coronary heart disease (CHD) complicated by ischemic left ventricular systolic dysfunction.
Through a prospective, multi-center, open-label 1:1 randomized controlled trial, a total of 452 patients with severe ischemic systolic dysfunction and complex coronary lesions were enrolled.
The study compared the 12-month incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) between patients who received interventional therapy supported by the CorVad percutaneous left ventricular assist system in addition to the most appropriate medical therapy and those who only received the most appropriate medical therapy.
This was done to test whether the interventional therapy supported by the CorVad percutaneous left ventricular assist system can improve the prognosis of patients with severe ischemic systolic dysfunction and complex coronary lesions.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
452
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前:Kefei Dou, MD, PhD
- 電話番号:+86-13801032912
- メール:drdoukefei@126.com
研究連絡先のバックアップ
- 名前:Guofeng Gao, MD
- 電話番号:+8613811458815
- メール:ggf03@163.com
研究場所
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Beijing、中国、100037
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
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コンタクト:
- Kefei Dou, MD, PhD
- 電話番号:+86-1380103291
- メール:drdoukefei@126.com
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主任研究者:
- Kefei Dou, MD, PhD
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- The subject is aged ≥18 years;
- The subject has been diagnosed with chronic or acute coronary syndrome and has a left ventricular ejection fraction <35%;
- After comprehensive evaluation by the cardiac team, it is considered that the subject may benefit from PCI treatment;
- The subject has signed an informed consent form approved by the ethics committee, has good compliance after discharge, and is willing to undergo clinical follow-up.
- At least two vascular occlusive lesions (with the diameter of the occluded vessel >2.5mm) or unprotected left main coronary artery disease, and meeting one or more complex procedural criteria, or three-vessel disease, and meeting two or more complex procedural criteria;
Exclusion Criteria:
- Received mechanical circulatory assistance devices (including IABP, ECMO, Impella, etc.) before randomization;
- Acute myocardial infarction within 7 days or undergoing thrombolytic therapy;
- Combined with aortic dissection, pulmonary embolism, or severe pulmonary hypertension;
- Patients with cardiogenic shock or hemodynamic instability;
- Cardiopulmonary resuscitation was performed before randomization;
- Mechanical complications (including ventricular perforation, interventricular septal perforation, mitral valve chordae rupture, etc.) confirmed before randomization and subsequent to acute myocardial infarction;
- The mechanical circulatory assist device cannot be implanted or there are contraindications (including but not limited to left ventricular mural thrombus, artificial aortic valve or cardiac contractile device, moderate or severe aortic stenosis, moderate or severe aortic regurgitation, presence of stents in peripheral vascular access, tortuosity, dissection, and other severe vascular lesions that hinder the implantation of the investigational device, aortic aneurysm or severe malformation abnormalities, blood cell fragility or hemolytic blood system diseases, hypertrophic or hypertrophic obstructive cardiomyopathy, etc.);
- Severe abnormalities in platelets, with a count below 50×10^9/L or above 600×10^9/L;
- Active visceral hemorrhage or hemorrhagic stroke occurs within 1 month;
- Unable to use antiplatelet or anticoagulant drugs;
- Has a history of drug allergy and cannot tolerate conventional cardiovascular drug therapy and intraoperative medications;
- Severe renal insufficiency, requiring or expected to require long-term dialysis treatment;
- Severe active infection, puncture site infection, sepsis, or septicemia;
- Life expectancy is less than or equal to 1 year;
- Women who are pregnant or breastfeeding;
- Severe right heart failure or severe tricuspid regurgitation;
- Participation in other clinical trials has not yet reached the primary endpoint;
- Other situations that are unforeseen or deemed unsuitable by the researcher's comprehensive judgment.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Microaxial flow pump-supported PCI plus optimal medical therapy (OMT) arm
Participants assigned to the intervention arm will undergo PCI supported by the micro-axial flow pump, in addition to optimal medical therapy (OMT).
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Use CorVad left ventricular assist system (micro-axial Flow Pump) to assist PCI in complex coronary artery disease with ischemic LV dysfunction patients
Guideline-directed OMT will be determined by the heart failure team at each center.
OMT may include antiplatelet therapy, lipid-lowering therapy, antianginal therapy, evidence-based heart failure therapy, blood pressure and glycemic control, lifestyle management, and other therapies appropriate to the patient's diagnosis and comorbidities.
Evidence-based heart failure therapy includes angiotensin converting enzyme inhibitor or angiotensin receptor blocker +/- neprilysin inhibitor, beta-blocker, mineralocorticoid receptor antagonist, sodium-glucose co-transporter 2 inhibitor, and vericiguat.
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他の:Optimal medical therapy (OMT) alone arm
Participants in this arms will receive guideline-directed optimal medical therapy (OMT) as determined by the heart failure team at each center.
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Guideline-directed OMT will be determined by the heart failure team at each center.
OMT may include antiplatelet therapy, lipid-lowering therapy, antianginal therapy, evidence-based heart failure therapy, blood pressure and glycemic control, lifestyle management, and other therapies appropriate to the patient's diagnosis and comorbidities.
Evidence-based heart failure therapy includes angiotensin converting enzyme inhibitor or angiotensin receptor blocker +/- neprilysin inhibitor, beta-blocker, mineralocorticoid receptor antagonist, sodium-glucose co-transporter 2 inhibitor, and vericiguat.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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1-year MACCE
時間枠:Up to 1 year after enrollment
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a composite endpoint consisting of cardiovascular death, spontaneous myocardial infarction, non-fatal stroke, ischemia-driven revascularization, and readmission for heart failure
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Up to 1 year after enrollment
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Perioperative myocardial infarction
時間枠:Up to 48h after the index PCI procedure
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Up to 48h after the index PCI procedure
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Types 3, 4, and 5 bleeding as defined by MCS-ARC
時間枠:Up to 1 year after enrollment
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Up to 1 year after enrollment
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Severe hemolysis related to the device
時間枠:Up to 72 hours after the implantation of the CorVad left ventricular assist system
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Up to 72 hours after the implantation of the CorVad left ventricular assist system
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Stent thrombosis
時間枠:Up to 1 year after the index PCI procedure
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Up to 1 year after the index PCI procedure
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2029年12月31日
研究の完了 (推定)
2029年12月31日
試験登録日
最初に提出
2026年4月14日
QC基準を満たした最初の提出物
2026年6月28日
最初の投稿 (実際)
2026年7月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月1日
QC基準を満たした最後の更新が送信されました
2026年6月28日
最終確認日
2026年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。