Clinical trials: Ischemic Lesions
Coronary Disease
Evaluate the Effectiveness and Cost of Stress Cardiac Magnetic Resonance Imaging (MRI) for Non-invasive Evaluation of Lesions Discovered on Computed Tomography Angiography (CCTA)
This study is designed to evaluate the effectiveness and measurable cost impact of stress cardiac MRI for non-invasive evaluation of intermediate lesions discovered on CCTA in low-to-intermediate risk patients admitted to the ED…
- Trial name
- DSTAT (NCT00538460)
- Where
- United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Corewell Health East
Ischemia Lesions
Polytetrafluoroethylen (PTFE) Vascular Prostheses With Heparin Bonded Luminal Surfaces vs Crude ePTFE
Open repair could be recommended in a first line of treatment to revascularize critical limb ischemia patients or performed in a second line of treatment in case of failure of endovascular repair.
- Trial name
- REPLACE (NCT03430076)
- Testing
- revascularization, Propaten®, Crude PTFE
- Where
- 21 sites in France
- Volunteers
- 228 people
- Sponsor
- Nantes University Hospital
Coronary Artery Disease, Coronary Disease
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
The INTERCLIMA (Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria Identified by Optical Coherence Tomography in Patients With Acute Coronary Syndrome) is a multi-center, prospective, randomized…
- Conditions
- Coronary Artery Disease, Coronary Disease, Ischemic Heart Disease
- Trial name
- INTERCLIMA (NCT05027984)
- Testing
- Optical coherence tomography, iFR/FFR/RFR
- Where
- 34 sites in Greece, Italy and 2 more
- Volunteers
- 1,425 people
- Sponsor
- Centro per la Lotta Contro l'Infarto - Fondazione Onlus
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
Stable Angina, Coronary Stenosis
The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study
A randomised open-label pilot study to assess the safety and efficacy of treatment with a drug eluting balloon alone in coronary de novo lesions).
- Trial name
- EXPEL (NCT01899235)
- Testing
- drug eluting balloon, drug eluting stent
- Where
- Denmark
- Sponsor
- Aalborg University Hospital
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
Coronary Artery Disease
BIOTRONIK Orsiro Pre-Marketing Registration
The clinical investigation is a non-inferiority, multicenter, blinding evaluation, randomized, parallel controlled clinical study enrolling up to 440 subjects.
- Trial name
- BIOFLOW-VI (NCT02870985)
- Testing
- Coronary Stent
- Where
- China
- Volunteers
- 440 people
- Sponsor
- Biotronik (Beijing) Medical Device Ltd.
Coronary Artery Disease
Atherectomy vs Intravascular Lithotripsy
Preliminary experiences show that IVL is promising for achieving an effective plaque modification at time of PCI. However, uncertainty about the optimal tool to select in case of calcification of coronary lesions exists, as no…
- Trial name
- RAINBOW (NCT04013906)
- Testing
- Rotational atherectomy
- Volunteers
- 100 people
- Sponsor
- University of Roma La Sapienza
Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery
DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions
The aim of the DYNAMITE study is to investigate the (a) acute procedural and (b) 9-month follow-up performance of DynamX Drug-Eluting Coronary Bioadaptor System implantation in complex coronary lesions.
- Conditions
- Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Bifurcation of Coronary Artery, Multi Vessel Coronary Artery Disease
- Trial name
- DYNAMITE (NCT05464147)
- Testing
- DynamX Drug-Eluting Coronary Bioadaptor System
- Where
- Italy
- Volunteers
- 55 people
- Sponsor
- Elixir Medical Corporation
Coronary Artery Disease
MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions
The purpose of this study is to demonstrate the efficacy of MagicTouch DCB in reducing late lumen loss / suppressing neointimal tissue formation as assessed by Quantitative Coronary Angiography / Intravascular Ultrasound…
- Trial name
- MAGIC-TOUCH (NCT02400632)
- Testing
- MAGIC-TOUCH Drug-eluting Balloon
- Where
- 3 sites in Brazil
- Volunteers
- 60 people
- Sponsor
- Scitech Produtos Medicos SA
Coronary Artery Disease
Evaluation of the Safety and Efficacy of Titanium-nitric Oxide-coated Stent (Optimax®) in Patients With Lesions With a Low Risk of Restenosis (Diameter ≥ 3.0 mm and Length ≤ 20 mm)
This prospective registry is intended to evaluate the safety and efficacy of the Optimax® stent.
- Trial name
- RETO 320 (NCT03737565)
- Testing
- Optimax stent®
- Where
- 5 sites in Spain
- Volunteers
- 350 people
- Sponsor
- Fundación EPIC
Coronary Artery Disease
A Safety and Efficacy of Supralimus™ Core™ Sirolimus Eluting Stent at MAX DDHV Institute
OBJECTIVES: The primary objective of this study is to assess the safety and efficacy of the Supralimus - Core™ Sirolimus Eluting Stent in de novo native vessel obstructive coronary artery disease.
- Trial name
- Maximus (NCT00811616)
- Testing
- Supralimus-Core™, Supralimus™ Core™ Sirolimus eluting stent
- Where
- India
- Volunteers
- 105 people
- Sponsor
- Sahajanand Medical Technologies Limited
Coronary Artery Stenosis, Coronary Arteriosclerosis
XIENCE V: SPIRIT WOMEN
The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female…
- Conditions
- Coronary Artery Stenosis, Coronary Arteriosclerosis, Coronary Artery Disease, Coronary Artery Restenosis
- Trial name
- NCT00496938
- Testing
- XIENCE V®/ XIENCE PRIME™
- Where
- 95 sites in Argentina, Australia and 24 more
- Volunteers
- 1,600 people
- Sponsor
- Abbott Medical Devices
Arterial Occlusion, Cardiovascular Diseases
Comparing TR Band to Statseal in Conjunction With TR Band II
The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transradial procedures.
- Conditions
- Arterial Occlusion, Cardiovascular Diseases, Atherosclerosis, Hematoma
- Trial name
- Statseal II (NCT04046952)
- Testing
- Statseal with TR Band, TR band only
- Where
- United States
- Volunteers
- 443 people
- Sponsor
- VA Long Beach Healthcare System
Coronary Artery Disease, Drug Eluting Stent
CREATE Trial, Prospective, Observational Study
Observation of the safety and effectiveness of Cre8 stent, Cre8 evo stent in patients with ischemic heart disease with long coronary lesions
- Trial name
- NCT05658250
- Testing
- CRE8 polymer-free Amphilimus-eluting stent, Cre8 evo stent
- Where
- South Korea
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Yonsei University
Drug Coated Balloon, Bioresorbable Scaffold
Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone
The goal of this study is to investigate the equivalence in early and long-term efficacy between the two "Leave nothing behind strategies" (Drug-Coated Baloon [DCB] strategy with bail-out BioResorbable Scaffold [BRS] versus BRS…
- Conditions
- Drug Coated Balloon, Bioresorbable Scaffold, Percutaneous Coronary Intervention (PCI), Acute Coronary Syndrome (ACS)
- Trial name
- LNB (NCT07038408)
- Testing
- Angioplasty with DCB (bail-out BRS), Angioplasty with BRS
- Where
- Estonia
- Volunteers
- 2,256 people
- Sponsor
- Ceric Sàrl
Peripheral Artery Disease, Critical Limb Ischemia
Complete Lesion Assessment With ffR and IVUS TechnologY
CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).
- Trial name
- CLARITY I (NCT01941030)
- Testing
- Orbital Atherectomy System, Balloon Angioplasty
- Where
- 8 sites in United States
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Peripheral Vascular Diseases
DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia
The purpose of this trial is to compare short- medium long-term results in treatment of PAD (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective …
- Trial name
- NCT02750605
- Testing
- DEB, POBA
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Skane University Hospital
Coronary Artery Disease
First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease
The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent SES.
- Trial name
- DESSOLVE-I (NCT01247428)
- Testing
- MiStent SES
- Where
- 5 sites in Australia, Belgium and 1 more
- Volunteers
- 30 people
- Sponsor
- Micell Technologies
Coronary Artery Disease, Calcification
Rotablation vs Intravascular Lithotripsy in Calcified Coronary Lesions
Prospective, 1:1 randomized, controlled, multicenter trial to assess effectiveness and safety of Intravascular Lithotripsy (IVL) compared to Rotational Atherectomy (RA) treatment in calcified coronary lesions
- Trial name
- DECALCIFY (NCT04960319)
- Testing
- Intravascular Lithotripsy
- Volunteers
- 100 people
- Sponsor
- Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.