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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

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

452

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Guofeng Gao, MD
  • Numero di telefono: +8613811458815
  • Email: ggf03@163.com

Luoghi di studio

      • Beijing, Cina, 100037
        • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contatto:
        • Investigatore principale:
          • Kefei Dou, MD, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
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).
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.
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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
1-year MACCE
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Perioperative myocardial infarction
Lasso di tempo: 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
Lasso di tempo: Up to 1 year after enrollment
Up to 1 year after enrollment
Severe hemolysis related to the device
Lasso di tempo: 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
Lasso di tempo: Up to 1 year after the index PCI procedure
Up to 1 year after the index PCI procedure

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

31 dicembre 2029

Completamento dello studio (Stimato)

31 dicembre 2029

Date di iscrizione allo studio

Primo inviato

14 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 giugno 2026

Primo Inserito (Effettivo)

1 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 giugno 2026

Ultimo verificato

1 gennaio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2025-2847

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .