Clinical trials: High-risk PCI
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
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
Coronary Artery Disease, Heart Failure
PULsecath mechanicaL Support Evaluation
The objective of this study is to determine ventricular loading conditions during and after PulseCath® iVAC2L support, and assess its impact on specific load dependent humoral factors and cardiac enzymes.
- Conditions
- Coronary Artery Disease, Heart Failure, Cardiogenic Shock
- Trial name
- PULSE (NCT03200990)
- Testing
- iVAC2L pVAD
- Where
- 3 sites in France, Netherlands and 1 more
- Volunteers
- 32 people
- Sponsor
- Erasmus Medical Center
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
Graft Versus Host Disease (GVHD)
Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone
Study CSL964_5001 will investigate the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD
- Trial name
- NCT04167514
- Testing
- Alpha-1 antitrypsin (AAT)
- Where
- 25 sites in United States
- Volunteers
- 136 people
- Sponsor
- CSL Behring
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.
Coronary Artery Disease
SHIELD II Clinical Investigation
The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with…
- Trial name
- SHIELD II (NCT02468778)
- Testing
- HeartMate PHP, Any Abiomed Impella® device approved for use in high-risk PCI
- Where
- 58 sites in United States
- Volunteers
- 54 people
- Sponsor
- Abbott Medical Devices
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 Artery Disease, Unstable Angina
Restore EF Observational Study
A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard…
- Conditions
- Coronary Artery Disease, Unstable Angina, Angina, Stable, NSTEMI - Non-ST Segment Elevation MI
- Trial name
- NCT04648306
- Testing
- Prophylactic Impella support for a non-emergent PCI
- Where
- 21 sites in United States
- Volunteers
- 406 people
- Sponsor
- Abiomed Inc.
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
Complex Higher Risk Indicated Patients Undergoing PCI
IVUS CHIP China Registry
The goal of this observational study is to learn about in patients with complex coronary lesions undergoing PCI. The main question[s] it aims to answer are: the clinical efficacy and safety of an IVUS-guided approach in patients…
- Trial name
- NCT06274645
- Testing
- The OptiCross High Definition (60 MHz) and OptiCross (40MHz) Intravascular Ultrasound (IVUS) catheter from Boston Scientific
- Where
- China
- Volunteers
- 2,020 people
- Sponsor
- Shanghai Zhongshan 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.