Clinical trials: Ischemic Lesions
Peripheral Vascular Disease
PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia
The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb…
- Trial name
- PADI (NCT00471289)
- Testing
- PTA with placement of paclitaxel-eluting stent, PTA
- Where
- 3 sites in Netherlands
- Volunteers
- 144 people
- Sponsor
- Netherlands Society for Interventional Radiology
Coronary Artery Disease Left Main
Imaging and Physiology for Intermediate Left Main Stem Stenosis
The present research aims to determine the impact of stenoses in downstream vessels on the FFR and iFR measurements of left main coronary artery (LMCA) stenoses of intermediate severity as determined by coronary angiography.
- Trial name
- VIP-LMS (NCT04531007)
- Testing
- iFR/ FFR/ IVUS/ OCT
- Where
- Brazil
- Volunteers
- 53 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Coronary Artery Disease
Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)
A Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion.
- Trial name
- NCT04058990
- Testing
- Device: Paclitaxel-Coated PTCA Balloon Catheter, SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel
- Where
- 14 sites in Japan
- Volunteers
- 180 people
- Sponsor
- Boston Scientific Corporation
Coronary Stenosis
Shockwave Coronary Lithoplasty Study
The objective of this clinical trial is to study the early safety and feasibility of the Shockwave Coronary Lithoplasty System. To demonstrate that the Shockwave device can safely and effectively deliver localized shockwave…
- Trial name
- NCT02758379
- Testing
- Shockwave Coronary Lithoplasty System
- Where
- Australia
- Volunteers
- 12 people
- Sponsor
- Shockwave Medical, Inc.
Coronary Artery Disease
Abbott Next Generation Drug Eluting Stent 48mm Study
The purpose of this SPIRIT 48 study is to evaluate the safety and effectiveness of the ABT NG DES 48 in improving coronary artery luminal diameter in subjects with coronary artery disease (CAD) due to de novo native coronary…
- Trial name
- SPIRIT 48 (NCT04282148)
- Testing
- ABT NG DES 48 EECSS
- Where
- 25 sites in United States, Australia and 1 more
- Volunteers
- 107 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Safety and Efficacy of the CRE8 Stent for the Treatment of De Novo Coronary Artery Lesions
The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8 sirolimus-eluting stent and the RESOLUTE zotarolimus-eluting stent in the treatment of patients with de novo coronary artery lesions.
- Trial name
- NCT02360423
- Testing
- CRE8 sirolimus-eluting stent, RESOLUTE zotarolimus-eluting stent
- Where
- China
- Volunteers
- 430 people
- Sponsor
- CID S.p.A.
Coronary Artery Disease, Coronary Bifurcation Lesion
Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy
The optimal treatment of coronary bifurcation lesions is complex and remains subject of current research. There is ongoing debate about the optimal strategy for bifurcations with upfront two-stent strategy or provisional…
- Trial name
- Hybrid DEB (NCT05731687)
- Testing
- Hybrid DEB approach with drug-eluting balloon, Two-stent strategy
- Where
- Netherlands
- Volunteers
- 500 people
- Sponsor
- Cathreine BV
Coronary Artery Disease
Everolimus-Eluting Stent for Bifurcation Coronary Lesions: Comparison of Simple Versus Complex Techniques
The purpose of this study is to evaluate the efficacy and safety of the treatment of true bifurcation lesions with the XIENCE V stent using the simple strategy (stent in main vessel and provisional T-stenting in the side branch)…
- Trial name
- NCT00916695
- Testing
- Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.
- Where
- 2 sites in Spain
- Volunteers
- 332 people
- Sponsor
- Spanish Society of Cardiology
Coronary Artery Disease
FFR vs. icECG in Coronary Bifurcations
The study hypothesis: it is possible to use icECG recorded from regular PCI wire to predict significance of SB ostial stenosis after main vessel stenting in coronary bifurcation lesions.
- Trial name
- FIESTA (NCT01724957)
- Testing
- Intracoronary ECG
- Where
- 2 sites in United States, Bulgaria
- Volunteers
- 37 people
- Sponsor
- University National Heart Hospital
Coronary Disease
Lipid Rich Necrotic Core Lesion Detected by Cardiac Magnetic Resonance Imaging (CMR)
The purpose of this study is to evaluate whether some features of plaques in coronary arteries predispose the heart muscle to injuries during angioplasty in patients with a narrowing in at least one of the arteries that may need…
- Trial name
- Hawaii (NCT01284270)
- Testing
- Cardiac MRI
- Sponsor
- Piedmont Healthcare
Coronary Artery Disease, Atherosclerotic Plaque
STabilization of Atheroma by Lipid-reducing Effect of Drug-Coated Balloon (STABLE-DCB)
This study aims to investigate whether DCB angioplasty, compared to statin-based medical treatment alone, will lead to more reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following…
- Conditions
- Coronary Artery Disease, Atherosclerotic Plaque, De Novo Stenosis
- Trial name
- STABLE-DCB (NCT05438121)
- Testing
- SeQuent Please Neo
- Where
- South Korea
- Volunteers
- 65 people
- Sponsor
- Korea University Ansan Hospital
Coronary Artery Disease
SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3
This study is a prospective, open-label, two-arm, randomized multicenter trial to compare the efficacy and safety of clopidogrel versus aspirin monotherapy beyond the standard duration of dual antiplatelet therapy (DAPT) (more…
- Trial name
- SMART-CHOICE3 (NCT04418479)
- Testing
- Aspirin, Clopidogrel
- Where
- South Korea
- Volunteers
- 5,506 people
- Sponsor
- Joo-Yong Hahn
Coronary Artery Disease
ANDREAS Registry (Assessment of Novel Drug-coated Balloon Revascularization: Effectiveness, Angiographic Outcomes, and Safety)
The primary objective of this protocol is to develop a comprehensive, multicenter international prospective registry to capture long-term clinical outcomes for adult patients undergoing percutaneous coronary intervention (PCI)…
- Trial name
- NCT07559903
- Where
- 19 sites in United States, Germany and 1 more
- Volunteers
- 5,000 people
- Sponsor
- Emory University
Coronary Artery Disease, De Novo Stenosis Lesion
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
A prospective, global, multi-centre, single-arm clinical study to evaluate the Safety and Performance of ADVA ACE Everolimus eluting Coronary Stent System in Coronary Artery Disease in Indian \& European population.
- Conditions
- Coronary Artery Disease, De Novo Stenosis Lesion, Coronary Stent Implantation
- Trial name
- ADVANCE (NCT07912541)
- Testing
- ADVA ACE Everolimus Eluting Coronary Stent System
- Volunteers
- 110 people
- Sponsor
- Advanced MedTech Solutions Pvt. Ltd.
Percutaneous Coronary Intervention
The Safety and Efficacy of DIOR Balloon in Coronary Bifurcation Lesions
To evaluate the safety and effectiveness of paclitaxel-eluting coronary artery balloon dilation catheter (DIOR) in revascularization of coronary bifurcation lesions compared with paclitaxel-eluting balloon (Bingo), and to provide…
- Trial name
- BEYOND-II (NCT03820622)
- Testing
- Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR), Paclitaxel-Eluting Balloon (Bingo)
- Where
- 13 sites in China
- Volunteers
- 220 people
- Sponsor
- CCRF Inc., Beijing, China
Coronary Artery Disease
Serial Changes After Drug-Coated Balloon
The study aims at evaluating the morphological changes of plaque estimated by optical coherence tomography (OCT) and Factors Influencing Plaque Healing after Drug-Coated Balloon (DCB) for de Novo Coronary Lesions.
- Trial name
- HEAL-aDCB (NCT04636931)
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The First Affiliated Hospital of Dalian Medical University
Coronary Disease, Coronary Artery Disease
MGuard Stent and Microcirculation
NSTE-ACS represents the most frequent indication for coronary angiography and percutaneous coronary intervention (PCI) worldwide.
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Atherosclerosis, Cardiovascular Diseases
- Trial name
- GUARDIANCORY (NCT03087175)
- Testing
- MGuard stent, Drug eluting stent and bare metal stent
- Where
- 2 sites in France
- Volunteers
- 52 people
- Sponsor
- University Hospital, Grenoble
Coronary Disease, Heart Diseases
Clinical Efficacy of Stent-balloon-stent (SBS) Technique in the Treatment of Coronary Bifurcation Lesions
The treatment of coronary bifurcation lesions continue to remain challenges. Due to the special hemodynamics caused by the special anatomical structure of the coronary bifurcation, it is easy to cause vascular crest displacement…
- Conditions
- Coronary Disease, Heart Diseases, Cardiovascular Diseases, Vascular Diseases
- Trial name
- NCT06045039
- Testing
- Stent-balloon-stent (SBS) technique
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Henan Institute of Cardiovascular Epidemiology
Perinatal Stroke
Baby Brain Recovery Study
This study will be a longitudinal multiple-visit observational study, done to identify possible bioindicators of recovery and repair of motor corticospinal pathways which may be targeted by future interventions in infants with…
- Trial name
- NCT05013736
- Testing
- Magnetic Resonance Imaging, Behavioral Assessments, Non invasive Transcranial Magnetic Stimulation
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- University of Wisconsin, Madison
Coronary Heart Disease
Drug-coated Balloon Therapy for In-stent Restenosis and de Novo Coronary Lesions
This was a single-center, prospective, open-label, observational study. Patients with coronary artery disease confirmed by coronary angiography and treated with drug-coated balloon catheter alone for target vessels were enrolled…
- Trial name
- NCT05552911
- Testing
- Pretreatment strategies before drug balloon therapy, Different types of in-stent restenosis were treated with drug-coated balloons
- Where
- China
- Volunteers
- 400 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University