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
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Kefei Dou, MD, PhD
- Numero di telefono: +86-13801032912
- Email: drdoukefei@126.com
Backup dei contatti dello studio
- Nome: Guofeng Gao, MD
- Numero di telefono: +8613811458815
- Email: ggf03@163.com
Luoghi di studio
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Beijing, Cina, 100037
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
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Contatto:
- Kefei Dou, MD, PhD
- Numero di telefono: +86-1380103291
- Email: drdoukefei@126.com
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Investigatore principale:
- Kefei Dou, MD, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: 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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Altro: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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1-year MACCE
Lasso di tempo: 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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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Perioperative myocardial infarction
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 2025-2847
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