- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07678021
Micro-axial Flow Pump-Supported PCI in Complex Coronary Artery Disease With Ischemic LV Dysfunction (PIVOT)
28 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
452
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Kefei Dou, MD, PhD
- Numéro de téléphone: +86-13801032912
- E-mail: drdoukefei@126.com
Sauvegarde des contacts de l'étude
- Nom: Guofeng Gao, MD
- Numéro de téléphone: +8613811458815
- E-mail: ggf03@163.com
Lieux d'étude
-
-
-
Beijing, Chine, 100037
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
-
Contact:
- Kefei Dou, MD, PhD
- Numéro de téléphone: +86-1380103291
- E-mail: drdoukefei@126.com
-
Chercheur principal:
- Kefei Dou, MD, PhD
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Autre: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
1-year MACCE
Délai: 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
|
Up to 1 year after enrollment
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Perioperative myocardial infarction
Délai: Up to 48h after the index PCI procedure
|
Up to 48h after the index PCI procedure
|
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Types 3, 4, and 5 bleeding as defined by MCS-ARC
Délai: Up to 1 year after enrollment
|
Up to 1 year after enrollment
|
|
Severe hemolysis related to the device
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
31 décembre 2029
Achèvement de l'étude (Estimé)
31 décembre 2029
Dates d'inscription aux études
Première soumission
14 avril 2026
Première soumission répondant aux critères de contrôle qualité
28 juin 2026
Première publication (Réel)
1 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 juin 2026
Dernière vérification
1 janvier 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025-2847
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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