Clinical trials: Ischemic Lesions
Coronary Disease
VH-IVUS Plaque Composition Analysis By Fractional Flow Reserve
Recent clinical trials demonstrated that virtual histology-intravascular ultrasound (VH-IVUS) is a useful test predicting clinical outcomes of the coronary artery disease (CAD).
- Trial name
- NCT01444599
- Where
- 4 sites in South Korea
- Volunteers
- 100 people
- Sponsor
- Inje University
Myocardial Infarction (MI), ST-Elevation Myocardial Infarction
Drug-Coated Balloon Primary PCI in ST-Segment Elevation Myocardial Infarction
Drug-eluting stent (DES)-based primary percutaneous intervention (pPCI) has been established as the standard of care for patients presenting with ST-segment elevation myocardial infarction (STEMI), having demonstrated superiority…
- Conditions
- Myocardial Infarction (MI), ST-Elevation Myocardial Infarction, STEMI, STEMI (STE-ACS)
- Trial name
- DCB-STEMI (NCT07436429)
- Testing
- Drug-Coated Balloon
- Where
- Austria
- Volunteers
- 300 people
- Sponsor
- Medical University of Vienna
Coronary Artery Disease
Vascular Response of Orsiro vs. Xience Drug-Eluting Stents for Treating Coronary Bifurcation Lesions
This study aims to compare vessel response and clinical outcomes of a biodegradable-polymer, ultra-thin strut, drug-eluting stent (Orsiro, Biotronik) and a durable-polymer, thin-strut, drug-eluting stent (Xience, Abbott) for the…
- Trial name
- NCT05200637
- Testing
- Orsiro stent, Xience stent, Any drug-eluting stent
- Where
- Taiwan
- Volunteers
- 150 people
- Sponsor
- Chang Gung Memorial Hospital
Ischemic Cardiovascular Disease
Multicenter Randomised Prospective Study for External Support Mesh VEST of Venous Coronary Grafts on the Right Territory
Multicentre randomised prospective study aimed at verifying medium-term patency of venous grafts on the right coronary artery territory, by clinical and/or instrumental follow-up with particular attention to clinically driven…
- Trial name
- RiVEST (NCT06877195)
- Testing
- CABG
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- Cardiochirurgia E.H.
Coronary Artery Disease
A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES)
PIONEER-II RCT trial is a prospective, multicenter, randomized, non-inferiority registry trial. 539 subjects from about 40 interventional cardiology centers in China will be enrolled to evaluate In-stent late lumen loss(LLL) as…
- Trial name
- RCT (NCT02698839)
- Testing
- BuMA Supreme, BuMA™
- Where
- China
- Volunteers
- 539 people
- Sponsor
- Sino Medical Sciences Technology Inc.
Coronary Artery Disease, Stenosis Coronary
SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective
The objective of the study is to compare angiographic outcomes of Selution sirolimus coated balloon (MedAlliance) versus SeQuent Please Neo paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions…
- Conditions
- Coronary Artery Disease, Stenosis Coronary, Coronary Artery Lesion, Percutaneous Coronary Intervention
- Trial name
- SPAGO (NCT06373601)
- Testing
- sirolimus-eluting balloon (Selution), paclitaxel-eluting balloon (SeQuent Please Neo)
- Where
- 10 sites in Italy
- Volunteers
- 140 people
- Sponsor
- Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Coronary Artery Disease, Peripheral Vascular Disease
Study of the SafeSeal(TM) Hemostasis Patch Following Percutaneous Coronary Artery and Peripheral Vascular Interventions
We seek to determine if the use of the SafeSeal(TM) topical hemostasis patch is associated with reductions in time to hemostasis and time to ambulation compared to standard manual compression after arterial sheath removal…
- Trial name
- NCT00481741
- Testing
- SafeSeal(TM) Hemostasis Patch
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Rochester
Coronary Artery Disease, Coronary Stenosis
Reverse T-stenting and Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation
The Reverse T-stenting And Minimal Protrusion (Reverse TAP) is an up-front 2-stent technique that treats complex coronary bifurcation.
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Coronary Disease
- Trial name
- T-REX (NCT05782738)
- Testing
- Percutaneous Coronary Intervention
- Where
- 5 sites in Italy
- Volunteers
- 361 people
- Sponsor
- San Luigi Gonzaga Hospital
Coronary Arteriosclerosis
Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent
The purpose of this study is: To evaluate the safety and performance of the Presillion stent in routine clinical practice.
- Trial name
- NCT00968019
- Testing
- Presillion stent
- Where
- 13 sites in Portugal, Spain
- Volunteers
- 318 people
- Sponsor
- Johnson and Johnson, S.A.
Coronary Artery Disease
Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion
The optimal treatment of calcified coronary lesion remained to be elucidated. A Prospective, randomized controlled trial was perform to explore the immediate effect and long-term outcome of rotational atherectomy in patients with…
- Trial name
- NCT01887704
- Testing
- Rotablator, conventional angioplasty, stenting
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Capital Medical University
Coronary Artery Disease
Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation
The primary objective is to determine whether IVUS- (vs. OCT-) guided BVS implantation is non-inferior to achieve a large in-scaffold minimal lumen area (primary endpoint) measured by OCT at 1-year follow-up.
- Trial name
- ACTIV-BVS (NCT02814578)
- Testing
- Optical coherent tomography, IntraVascular UltraSound
- Where
- 3 sites in South Korea
- Volunteers
- 9 people
- Sponsor
- Young-Hak Kim, MD, PhD
NSTEMI - Non-ST Segment Elevation MI, Multi Vessel Coronary Artery Disease
Culprit Lesions in NSTEMI With Multi Vessel Disease (NSTEMI-CULPRIT)
Acute myocardial infarction owes to a plaque rupture resulting in total (STEMI) or partial occlusion (NSTEMI) of the coronary artery.
- Trial name
- NS-CULPRIT (NCT03479593)
- Testing
- CMR and OCT in NSTEMI patients with MVD
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
De Novo Stenosis, Coronary Artery Disease
Bioresorbable Sirolimus-eluting scaffold in de Novo Coronary Artery Lesions
Bioresorbable scaffold (BRS) was designed aiming to avoid the late adverse events associated with permanent metallic stents by providing temporary support to the vessel wall and promoting vessel remodeling, plaque reduction, and…
- Trial name
- REC-CAGEFREE Ⅳ (NCT07022587)
- Testing
- Sirolimus-eluting bioresorbable scaffolds, Sirolimus-eluting stents
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Xijing Hospital
Ischemic Heart Disease, Stenotic Coronary Lesion
RESOLUTE China Registry:
To document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a real-world patient population requiring stent implantation.
- Conditions
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis
- Trial name
- R-C Registry (NCT01243749)
- Where
- 6 sites in China
- Volunteers
- 1,800 people
- Sponsor
- Medtronic Vascular
Coronary Artery Disease
Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization
The FAST III is a randomized controlled, open-label, multicenter, international, non-inferiority, strategy trial. A total of 2228 participants will be randomized in a 1:1 fashion to either vFFR- or FFR guided revascularization.
- Trial name
- FAST III (NCT04931771)
- Testing
- vFFR guided revascularization, FFR guided revascularization
- Where
- 40 sites in France, Germany and 5 more
- Volunteers
- 2,235 people
- Sponsor
- ECRI bv
Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
MIRAGE Study: Clinical Outcomes of the Mamba Sirolimus-Eluting PTCA Balloon
This Clinical Evaluation Report (CER) covers the Mamba Sirolimus-Eluting PTCA Balloon catheter intended for the treatment of coronary artery disease in de novo or in-stent restenosis lesions.
- Trial name
- NCT07326735
- Testing
- Mamba Sirolimus-Eluting PTCA Balloon, Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon
- Where
- 2 sites in Burma, Malaysia
- Volunteers
- 360 people
- Sponsor
- Frisch Medical Device Private Limited
Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3)
Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease
Prospective, multi-center single-arm observational study A total of 100 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included.
- Conditions
- Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3), Critical Limb Ischemia (Rutherford Category 4 or 5)
- Trial name
- K-ELUVIA (NCT06234280)
- Testing
- Implantation of Eluvia stent
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Yonsei University
Coronary Artery Disease, Stable Angina
Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: The PREDICT Study
The purpose of this study is to assess whether the use of physiology parameters as guidance post-percutaneous coronary interventions (PCI) is associated with less risks of target vessel failure (TVF) and angina-related events…
- Conditions
- Coronary Artery Disease, Stable Angina, Unstable Angina, Ischemic Heart Disease
- Trial name
- EASY-PREDICT (NCT04929496)
- Testing
- post-PCI FFR
- Where
- Canada
- Volunteers
- 221 people
- Sponsor
- Laval University
Coronary Artery Disease
Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions
TAXUS ATLAS Direct Stent is a global, multi-center, single-arm, noninferiority trial comparing results from patients in whom the TAXUS Liberté stent was directly implanted (direct stenting) versus results from patients in whom…
- Trial name
- NCT00371423
- Testing
- TAXUS Liberté™-SR
- Where
- 25 sites in United States, New Zealand and 2 more
- Volunteers
- 247 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease
Pilot Clinical Study of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System
MeRes-1 Extend study is designed as prospective, multinational, multicentre, single arm, open label, pilot study to assess the safety and performance of the MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System (BRS)…
- Trial name
- MeRes-1Extend (NCT02663323)
- Testing
- MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System
- Where
- 4 sites in Brazil, Indonesia and 2 more
- Volunteers
- 64 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.