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Micro-axial Flow Pump-Supported PCI in Complex Coronary Artery Disease With Ischemic LV Dysfunction (PIVOT)

2026년 6월 28일 업데이트: 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.

연구 개요

연구 유형

중재적

등록 (추정된)

452

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

  • 이름: Guofeng Gao, MD
  • 전화번호: +8613811458815
  • 이메일: ggf03@163.com

연구 장소

      • Beijing, 중국, 100037
        • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
        • 연락하다:
        • 수석 연구원:
          • Kefei Dou, MD, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. The subject is aged ≥18 years;
  2. The subject has been diagnosed with chronic or acute coronary syndrome and has a left ventricular ejection fraction <35%;
  3. After comprehensive evaluation by the cardiac team, it is considered that the subject may benefit from PCI treatment;
  4. 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.
  5. 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:

  1. Received mechanical circulatory assistance devices (including IABP, ECMO, Impella, etc.) before randomization;
  2. Acute myocardial infarction within 7 days or undergoing thrombolytic therapy;
  3. Combined with aortic dissection, pulmonary embolism, or severe pulmonary hypertension;
  4. Patients with cardiogenic shock or hemodynamic instability;
  5. Cardiopulmonary resuscitation was performed before randomization;
  6. Mechanical complications (including ventricular perforation, interventricular septal perforation, mitral valve chordae rupture, etc.) confirmed before randomization and subsequent to acute myocardial infarction;
  7. 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.);
  8. Severe abnormalities in platelets, with a count below 50×10^9/L or above 600×10^9/L;
  9. Active visceral hemorrhage or hemorrhagic stroke occurs within 1 month;
  10. Unable to use antiplatelet or anticoagulant drugs;
  11. Has a history of drug allergy and cannot tolerate conventional cardiovascular drug therapy and intraoperative medications;
  12. Severe renal insufficiency, requiring or expected to require long-term dialysis treatment;
  13. Severe active infection, puncture site infection, sepsis, or septicemia;
  14. Life expectancy is less than or equal to 1 year;
  15. Women who are pregnant or breastfeeding;
  16. Severe right heart failure or severe tricuspid regurgitation;
  17. Participation in other clinical trials has not yet reached the primary endpoint;
  18. Other situations that are unforeseen or deemed unsuitable by the researcher's comprehensive judgment.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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).
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.
다른: 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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
1-year MACCE
기간: Up to 1 year after enrollment
a composite endpoint consisting of cardiovascular death, spontaneous myocardial infarction, non-fatal stroke, ischemia-driven revascularization, and readmission for heart failure
Up to 1 year after enrollment

2차 결과 측정

결과 측정
기간
Perioperative myocardial infarction
기간: Up to 48h after the index PCI procedure
Up to 48h after the index PCI procedure
Types 3, 4, and 5 bleeding as defined by MCS-ARC
기간: Up to 1 year after enrollment
Up to 1 year after enrollment
Severe hemolysis related to the device
기간: Up to 72 hours after the implantation of the CorVad left ventricular assist system
Up to 72 hours after the implantation of the CorVad left ventricular assist system
Stent thrombosis
기간: Up to 1 year after the index PCI procedure
Up to 1 year after the index PCI procedure

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2029년 12월 31일

연구 완료 (추정된)

2029년 12월 31일

연구 등록 날짜

최초 제출

2026년 4월 14일

QC 기준을 충족하는 최초 제출

2026년 6월 28일

처음 게시됨 (실제)

2026년 7월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 28일

마지막으로 확인됨

2026년 1월 1일

추가 정보

이 연구와 관련된 용어

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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