Clinical trials: High-risk Percutaneous Coronary Intervention
Acute Coronary Syndrome
Reloading Prasugrel or Clopidogrel on High Platelet Reactivity Before Percutaneous Coronary Intervention
High platelet reactivity unit (PRU) after loading dose clopidogrel in patients undergoing percutaneous coronary intervention (PCI) is related to high risk of short and long term recurrent ischemic events including stent…
- Trial name
- PRAISE-HPR (NCT01609647)
- Testing
- Prasugrel, Clopidogrel
- Where
- South Korea
- Volunteers
- 76 people
- Sponsor
- Dong-A University
Acute Coronary Disease, Angina Unstable
Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS
The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin (two doses) will decrease the risk of ischemic complications (cardiac death (CV death), myocardial infarction (MI), stroke) after a…
- Trial name
- CURRENT/OASIS7 (NCT00335452)
- Testing
- Clopidogrel, acetylsalicyclic acid (ASA)
- Where
- 38 sites in United States, Argentina and 36 more
- Volunteers
- 25,086 people
- Sponsor
- Sanofi
PCI, Coronary Arterial Disease (CAD)
Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions
this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing…
- Conditions
- PCI, Coronary Arterial Disease (CAD), Calcified Coronary Lesions
- Trial name
- Shape (NCT07093788)
- Testing
- super high-pressure balloon, intravascular lithotripsy (IVL)
- Where
- 3 sites in China
- Volunteers
- 78 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Myocardial Infarction
Prasugrel in Comparison to Clopidogrel for Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI)
This is a single-center, randomized, single-blind, investigator-initiated, pharmacological study with a parallel design. Patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention and…
- Trial name
- PRO-GR-4 (NCT01338909)
- Testing
- Prasugrel, Clopidogrel
- Where
- Greece
- Volunteers
- 35 people
- Sponsor
- University of Patras
Primary PCI for STEMI
Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention (PCI)
200 consecutive patients presenting with STEMI within 12 hours from the onset of symptoms and having a high thrombotic burden at coronary angiography, defined as the presence of a thrombus size ≥ 2 times the diameter of the…
- Trial name
- NCT01472718
- Testing
- coronary thrombectomy, standard primary PCI (with stenting, as required)
- Volunteers
- 208 people
- Sponsor
- University of Pisa
Shock, Cardiogenic, High Risk Percutaneous Coronary Interventions
Synchronized Cardiac Assist for Cardiogenic Shock
The purpose of this study is to collect prospective safety and performance information for the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung failure or in high risk percutaneous…
- Trial name
- NCT02697006
- Testing
- i-cor Synchronized Cardiac Assist Device
- Where
- Germany
- Volunteers
- 47 people
- Sponsor
- Xenios AG
Coronary Artery Disease
The Effects of Tirofiban in Diabetic Patients Undergoing Elective Percutaneous Coronary Intervention
The purpose of this study is to examine the effects of tirofiban on platelet function the Ultegra RPFA in diabetic patients undergoing elective coronary angioplasty and stenting already treated with high loading dose (600mg)…
- Trial name
- NCT00407771
- Testing
- Tirofiban
- Where
- Jordan
- Volunteers
- 44 people
- Sponsor
- Jordan Hospital
Coronary Artery Disease
Phimume® Percutaneous Left Ventricular Assist System Study
The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus extracorporeal membrane oxygenation (ECMO) for circulatory support during high-risk PCI.
- Trial name
- NCT06639321
- Testing
- Percutaneous Ventricular Assist System, extracorporeal membrane oxygenation (ECMO)
- Where
- 6 sites in China
- Volunteers
- 250 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
ST Elevation Myocardial Infarction
Remote Ischemic Conditioning With Local Ischemic Postconditioning in High-Risk ST-elevation Myocardial Infarction
The RIP-HIGH trial is a two-arm randomized controlled trial aiming to compare the impact of combined remote ischemic conditioning (RIP) and local ischemic postconditioning (PostC) vs.
- Trial name
- RIP-HIGH (NCT04844931)
- Testing
- RIC + PostC + Standard PCI, Standard PCI
- Where
- 11 sites in Austria, Germany
- Volunteers
- 250 people
- Sponsor
- Helios Health Institute GmbH
High Bleeding Risk, Coronary Artery Disease
Zotarolimus vs Sirolimus Eluting Stent in High Bleeding Risk
Randomized, single-blind, single-center, non-inferiority clinical trial to compare target lesion failure (TLF) at 12 months in high bleeding risk patients who underwent elective coronary percutaneous intervention with a…
- Conditions
- High Bleeding Risk, Coronary Artery Disease, Percutaneous Coronary Intervention
- Trial name
- ZEVS-HBR (NCT05240781)
- Testing
- Zotarolimus eluting stent, Sirolimus eluting stent
- Where
- Mexico
- Volunteers
- 280 people
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
High-Risk PCI
SAVE-PCI: NyokAssist™ Small-Bore VAD vs. IABP in Elective High-Risk PCI
SAVE-PCI is a prospective, multi-center, randomized controlled trial evaluating the safety and efficacy of NyokAssist™, a small-bore percutaneous ventricular assist device (pVAD), in comparison with intra-aortic balloon pump…
- Trial name
- NCT07010965
- Testing
- NyokAssist™, IABP Intra-aortic balloon pump
- Where
- 12 sites in China
- Volunteers
- 236 people
- Sponsor
- magAssist, Inc.
Heart Diseases, Coronary Artery Disease (CAD)
Feasibility Study SA of the Supira System for HRPCI
The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing high-risk percutaneous interventions (HRPCI).
- Conditions
- Heart Diseases, Coronary Artery Disease (CAD), Heart Failure
- Trial name
- NCT05864248
- Testing
- Supira System
- Where
- 2 sites in Brazil
- Volunteers
- 71 people
- Sponsor
- Supira Medical
Acute Myocardial Infarction
REsistance to Aspirin and Clopidogrel in acuTe Myocardial Infarction
The purpose of this study is to compare 3 point-of-care methods for monitoring antiplatelet therapy to golden standard (Light transmittance aggregometry-LTA) in high risk population of acute myocardial infarction patients.
- Trial name
- REACT-MI (NCT01381185)
- Testing
- Aspirin 200mg qd, Clopidogrel 2x75mg qd
- Where
- 2 sites in Czechia
- Volunteers
- 154 people
- Sponsor
- University Hospital Ostrava
Coronary Disease, Heart Diseases
Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)
This international, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) compared to dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients…
- Conditions
- Coronary Disease, Heart Diseases, Cardiovascular Diseases, Myocardial Ischemia
- Trial name
- PIV-EPIC (NCT06535568)
- Testing
- Drug-coated balloon, Single antiplatelet therapy (SAPT), Dual antiplatelet therapy (DAPT)
- Where
- Italy
- Volunteers
- 576 people
- Sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
ST-segment Elevation Myocardial Infarction (STEMI)
Thrombus Aspiration in STEMI Patients With High Thrombus Burden
This is a prospective, multicenter, open-label, randomized, controlled, parallel group study, in which ST-segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(TIMI thrombus grade ≥3) are included.
- Trial name
- NCT04212494
- Testing
- Thrombus aspiration, PCI Alone
- Where
- 50 sites in China
- Volunteers
- 3,838 people
- Sponsor
- Guangdong Provincial People's Hospital
Acute Coronary Syndrome, Hyperlipidemias
PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With ACS After PCI
The primary objective was to evaluate the effect of PCSK 9 Inhibitor (initiated within 4 h from PCI for the culprit lesion) with high-intensity statin treatment, compared to placebo with high-intensity statin treatment, on…
- Conditions
- Acute Coronary Syndrome, Hyperlipidemias, Percutaneous Coronary Intervention, Cardiovascular Events
- Trial name
- SHAWN (NCT05457582)
- Testing
- PCSK 9 Inhibitor plus high-intensity statin
- Where
- China
- Volunteers
- 1,212 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Percutaneous Coronary Intervention, Coronary Artery Disease
Clinical Evaluation of A New High-speed and High-resolution Intravascular Ultrasound System
Insight Lifetech Intravascular Ultrasound Diagnostic System (referred to as Insight Lifetech IVUS system below),is a new high-speed and high-resolution device for clearly defining vessel architecture and plaque morphology…
- Conditions
- Percutaneous Coronary Intervention, Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Left Main Coronary Artery Disease
- Trial name
- NEW-IVUS (NCT04739657)
- Testing
- Insight Lifetech IVUS System, Boston Scientific IVUS System
- Where
- 5 sites in China
- Volunteers
- 130 people
- Sponsor
- Insight Lifetech Co., Ltd.
Acute Myocardial Infarction, Primary Percutaneous Coronary Intervention
Closed Versus Open Cells Stent for Acute Myocardial Infarction
The aim of this study is to determine whether a closed cell stent design may reduce distal embolization and no reflow during primary percutaneous coronary intervention (PPCI) for acute ST-elevation acute myocardial infarction…
- Trial name
- COCHISE (NCT01152138)
- Testing
- Open cells stent, Closed Cells Stent
- Where
- 2 sites in Italy
- Volunteers
- 223 people
- Sponsor
- Alessandro Sciahbasi
Bleeding Complications
Clopidogrel Monotherapy in Patients With High Bleeding Risk
The goal of this research is to show that a shorter duration of two antiplatelet medications (compared to the standard of care) is safe and effective while reducing the risk of bleeding complications.
- Trial name
- NCT05223335
- Testing
- Clopidogrel, Prasugrel, Tricagrelor
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- Mayo Clinic
Acute Myocardial Infarction, Heart Failure
Peri-treatment of SGLT-2 Inhibitor on Myocardial Infarct Size and Remodeling Index in Patients With Acute Myocardial Infarction and High Risk of Heart Failure Undergoing Percutaneous Coronary Intervention
We aimed to identify whether SGLT-2 inhibitor administration before and after coronary intervention is effective in reducing the size of infarction and myocardial remodeling in patients with acute myocardial infarction (AMI) and…
- Trial name
- PRESTIGE-AMI (NCT04899479)
- Testing
- SGLT2 inhibitor, Control
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Samsung Medical Center