Micro-axial Flow Pump-Supported PCI in Complex Coronary Artery Disease With Ischemic LV Dysfunction (PIVOT)
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
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Kefei Dou, MD, PhD
- Telefonnummer: +86-13801032912
- E-mail: drdoukefei@126.com
Undersøgelse Kontakt Backup
- Navn: Guofeng Gao, MD
- Telefonnummer: +8613811458815
- E-mail: ggf03@163.com
Studiesteder
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Beijing, Kina, 100037
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
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Kontakt:
- Kefei Dou, MD, PhD
- Telefonnummer: +86-1380103291
- E-mail: drdoukefei@126.com
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Ledende efterforsker:
- Kefei Dou, MD, PhD
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Eksperimentel: 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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Andet: 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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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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1-year MACCE
Tidsramme: 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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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Perioperative myocardial infarction
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 2025-2847
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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