Clinical trials: PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
Study Background \& Purpose: The no-reflow phenomenon is a significant complication occurring in patients with acute myocardial infarction who undergo percutaneous coronary intervention (PCI).
- Conditions
- No Reflow Phenomenon, Reperfusion Injuries, Myocardial, Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction
- Trial name
- NCT07898709
- Testing
- Empagliflozin (SGLT2i), dapagliflozin, Standard medical treatment
- Where
- 4 sites in Egypt
- Volunteers
- 100 people
- Sponsor
- Al-Azhar University
Ischemia, Myocardial, Coronary Artery Disease
Comparison of an Ultra-low Strut Thickness Everolimus-eluting Biodegradable Polymer Stent Versus Durable Polymer Everolimus-eluting Stents in Patients Treated With Percutaneous Coronary Intervention
The objective of this randomized study is to compare the safety and efficacy of the ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent to the everolimus-eluting family stents (durable polymer…
- Conditions
- Ischemia, Myocardial, Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)
- Trial name
- SORT OUT XII (NCT06692140)
- Testing
- Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s), PCI with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent(s))
- Where
- 3 sites in Denmark
- Volunteers
- 3,150 people
- Sponsor
- Odense University Hospital
Percutaneous Coronary Intervention (PCI), Coronary Arterial Disease (CAD)
Medipixel XA-Assisted PCI in Coronary Artery Disease
This prospective, multicenter, single-arm, interventional study evaluates the effectiveness and safety of Medipixel XA-Assisted Percutaneous Coronary Intervention (MPXA-PCI) in patients with coronary artery disease (CAD).
- Trial name
- MAP I (NCT06985693)
- Testing
- Medipixel XA-Assisted Percutaneous Coronary Intervention
- Where
- 6 sites in South Korea
- Volunteers
- 830 people
- Sponsor
- CHA University
PCI Patients, de Novo Coronary Lesions
iLITE, Clinical Performance of the Angiolite™ Drug-Eluting Stent
Prospective, multi-center, all comers, post market clinical follow-up (PMCF) registry.
- Conditions
- PCI Patients, de Novo Coronary Lesions, Restenotic Coronary Lesions, Acute Myocardial Infarction (AMI)
- Trial name
- iLITE (NCT07887230)
- Testing
- Percutaneous Coronary Intervention
- Volunteers
- 5,000 people
- Sponsor
- iVascular S.L.U.
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
IVUS-Guided Sirolimus-Coated Balloon Versus Sirolimus-Eluting Stent for De Novo Large Vessel Lesions in ACS
The goal of this interventional study is to evaluate the efficacy and safety of an intravascular ultrasound (IVUS)-guided sirolimus-coated balloon (SCB)-based strategy versus planned sirolimus-eluting stent (SES) implantation in…
- Trial name
- IVUS-SCB (NCT07796412)
- Testing
- IVUS-Guided Sirolimus-Coated Balloon, IVUS-Guided Sirolimus-Eluting Stent
- Where
- China
- Volunteers
- 150 people
- Sponsor
- China National Center for Cardiovascular Diseases
High-Risk Percutaneous Coronary Intervention (High-risk PCI)
ELEVATE High-Risk PCI Pivotal Study
The ELEVATE III Pivotal Study is a prospective, multi-center, open-label, interventional, randomized, controlled study with an active control group.
- Trial name
- ELEVATE III (NCT07001332)
- Testing
- Elevate, Impella
- Where
- 33 sites in United States
- Volunteers
- 290 people
- Sponsor
- Magenta Medical Ltd.
Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI)
Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2)
The primary aim of this study is to investigate the PD effects of switching from standard-dose clopidogrel dose to low-dose prasugrel versus continuing standard-dose clopidogrel in patients at dual-risk (HBR defined as the…
- Trial name
- NCT07025148
- Testing
- Prasugrel, Clopidogrel
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Florida
High-risk PCI
SAVE-PCI Ⅱ: NyokAssist™ Small-Bore VAD vs. ECMO in Elective High-Risk PCI
SAVE-PCI Ⅱ 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 ECMO in patients undergoing…
- Trial name
- NCT07860671
- Testing
- NyokAssist, ECMO
- Where
- 14 sites in China
- Volunteers
- 204 people
- Sponsor
- magAssist, Inc.
STEMI - ST Elevation Myocardial Infarction (MI), Primary PCI - STEMI
Early Intracoronary N-Acetylcysteine During Primary PCI in STEMI: A Pilot Randomized Trial of Reperfusion Injury Biomarkers and Functional Recovery
Myocardial ischemia-reperfusion injury still poses a major therapeutic challenge in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).
- Trial name
- NCT06850831
- Testing
- Antipac
- Where
- Indonesia
- Volunteers
- 110 people
- Sponsor
- dr. Ahmad Yasa, Sp.JP, Subsp.K.I.(K), M.Kes, FIHA, FasCC, FA
Ethics, Cardiac Rehabilitation
The Role of 4 Different Consent Approaches on a Pilot Study to Increase Cardiac Rehabilitation Attendance
Cardiac Rehabilitation is a lifestyle and exercise program for patients with heart disease. Cardiac Rehabilitation is strongly recommended in guidelines, but only 30% of eligible patients attend.
- Conditions
- Ethics, Cardiac Rehabilitation, Coronary Heart Disease (CHD), Heart Failure
- Trial name
- MOST-CR (NCT07123480)
- Testing
- Usual Care Group, More Support and Tools
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Baystate Medical Center
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
Minicrush Versus Culotte Stenting in Complex Coronary Bifurcation Lesions:The Multicenter T-REX II Registry
Percutaneous coronary intervention (PCI) of complex coronary bifurcation lesions frequently requires an upfront two-stent strategy.
- Conditions
- Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI), Bifurcation Coronary Artery Disease
- Trial name
- NCT07849335
- Testing
- Percutaneous Coronary Intervention with Minicrush
- Where
- Italy
- Volunteers
- 500 people
- Sponsor
- San Luigi Gonzaga Hospital
Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI)
Trends and Risk Factors of Adverse Cardiovascular and Cerebrovascular Events After Primary PCI
This single-center, ambispective cohort study will use real-world data from Zhongshan Hospital, Fudan University. About 8,000 patients aged 18 years or older with acute myocardial infarction (AMI) who underwent primary…
- Trial name
- TRACE-pPCI (NCT07833995)
- Testing
- Collection of baseline characteristics
- Where
- China
- Volunteers
- 8,000 people
- Sponsor
- Shanghai Zhongshan Hospital
Coronary Arterial Disease (CAD), Acute Coronary Syndromes (ACS)
Non-Invasive Follow-Up of Patients With Coronary Artery Disease Treated With Drug-Coated Balloon PCI Using CT-Derived Fractional Flow Reserve
This study investigates changes in coronary artery anatomy and physiology after treatment with a paclitaxel drug-coated balloon (DCB) during percutaneous coronary intervention (PCI).
- Conditions
- Coronary Arterial Disease (CAD), Acute Coronary Syndromes (ACS), Stable Coronary Artery Disease Undergoing PCI
- Trial name
- RECORD-CT-FFR (NCT07811960)
- Volunteers
- 150 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
First-in-Human Study Using the SiroMax™ Sirolimus-Coated Balloon Catheter as a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to Treat Subjects Who Have Coronary Artery Disease (CAD) Involving In-Stent Restenosis (ISR) or an Unstented Lesion in a Small Coronary Vessel (DNSV).
The goal of this clinical trial is to learn if the SiroMax™ drug-coated balloon catheter is safe and works to treat stenotic coronary lesions in adults.
- Conditions
- Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), In-Stent Restenosis or De Novo Coronary Artery Lesions, In-Stent Stenosis (Restenosis) of Coronary Artery Stent
- Trial name
- SMART-I (NCT07811024)
- Testing
- Sirolimus-coated balloon catheter
- Where
- 2 sites in Uzbekistan
- Volunteers
- 60 people
- Sponsor
- Tonic Medical, Inc.
PCI Patients, Single Coronary Vessel Disease
Non-Invasive Coronary Functional Evaluation of Patients With Single-vessel Coronary Artery Disease
Persistent or recurrent angina after successful percutaneous coronary intervention (PCI) remains a common clinical problem, affecting approximately 20-30% of patients despite complete epicardial coronary revascularization.
- Trial name
- NICE-CAD-PCI (NCT07805187)
- Testing
- Coronary flow reserve assessed by Echocardiography
- Volunteers
- 32 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coronary Artery Disease, Diffuse Coronary Artery Disease
Hybrid Percutaneous Coronary Intervention Combining a Bioresorbable Scaffold With Drug-coated Balloons Versus a Conventional Drug-eluting Stent-based Strategy in Patients With Long and Diffuse Coronary Artery Disease
The primary objective of the study is to assess the safety and the efficacy of a hybrid percutaneous coronary intervention (PCI) strategy combining a magnesium-based sirolimus-eluting bioresorbable scaffold (Freesolve, Biotronik…
- Conditions
- Coronary Artery Disease, Diffuse Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)
- Trial name
- BIOHYBRID (NCT06710210)
- Testing
- PCI with a bioresorbable scaffold and drug-coated balloon(s), PCI with drug-eluting stent(s)
- Where
- 4 sites in Switzerland
- Volunteers
- 150 people
- Sponsor
- University Hospital, Geneva
PCI, Drug-coated Balloon
Impact of Procedural Factors on Drug-Coated Balloon Outcomes in Coronary Artery Disease
This registry aimed to investigate drug-coated balloon procedural factors (particularly delivery time and inflation duration) to evaluate the impact on angiographic and clinical outcomes in patients undergoing percutaneous…
- Conditions
- PCI, Drug-coated Balloon, Coronary Artery Disease
- Trial name
- DT (NCT07764094)
- Where
- 7 sites in China
- Volunteers
- 500 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Myocardial Infarction, Percutaneous Coronary Intervention (PCI)
Investigation to Assess the Effects of Drug-COATED Balloons for Treatment of Plaques Erosions Causing Acute Coronary Syndromes
Drug eluting balloon angioplasty might be a better alternative than medical treatment or stenting in subjects with plaque erosion, which is the second most common cause of myocardial infarction.
- Conditions
- Myocardial Infarction, Percutaneous Coronary Intervention (PCI), Medical Treatment, Coronary Computed Tomographic Angiography
- Trial name
- DCB-PE (NCT07783880)
- Testing
- PCI with size matched DCB, GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy
- Where
- Poland
- Volunteers
- 62 people
- Sponsor
- 3W-Research Collaboration Group
Acute ST-segment Elevation Myocardial Infarction (Patients Undergoing Emergency PCI)
Efficacy and Safety of Ultrasound Modulation of Stellate Ganglion for the Prevention of Ventricular Arrhythmia in Patients With ST-segment Elevation Myocardial Infarction
The goal of this multicenter, double-blind, randomized controlled trial is to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) stellate ganglion modulation for preventing ventricular arrhythmias after…
- Trial name
- US-PRAY (NCT07587294)
- Testing
- Ultrasound modulation of the left stellate ganglion
- Where
- 7 sites in China
- Volunteers
- 100 people
- Sponsor
- Renmin Hospital of Wuhan University
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), Hypercholerolemia
Cardiovascular-kidney-metabolic (CKM)-Guided Therapy for Patients After Acute Coronary Syndrome
Patients with a history of myocardial infarction are at significantly increased risk of recurrent cardiovascular events. Despite established clinical guidelines, secondary preventive care is often initiated too late, inadequate…
- Conditions
- Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), Hypercholerolemia, Hypertension, Diabete Mellitus
- Trial name
- SLIM-3 (NCT07773272)
- Testing
- Rapid ESC-guideline based secondary prevention following myocardial infaction
- Where
- Netherlands
- Volunteers
- 1,215 people
- Sponsor
- Zuyderland Medisch Centrum