Clinical trials: Chronic Total Coronary Occlusions
Coronary Artery Disease, Coronary Disease
Sapphire 3 CTO Study
A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device performance of the Sapphire 3 0.85, 1.0 and 1.25mm diameter coronary dilatation catheter in predilatation…
- Conditions
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases
- Trial name
- NCT06358508
- Testing
- Sapphire 3 Coronary Dilatation Catheter
- Where
- 14 sites in United States, Spain
- Volunteers
- 170 people
- Sponsor
- OrbusNeich
Coronary Occlusion
Single-Arm Study Evaluating Use of the CORA Catheters for the Crossing of Coronary Chronic Total Occlusions
The goal of this clinical trial is to evaluate the safety and effectiveness of the coraFlex, coraForce, and coraCross catheters for crossing chronic total occlusions of the coronary arteries.
- Trial name
- Cora CTO (NCT05848232)
- Testing
- coraFlex Catheter, coraForce Catheter, coraCross Catheter
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- ReFlow Medical, Inc.
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.
Chronic Total Occlusion of Coronary Artery
Safety and Efficacy Study of the SoundBite™ Crossing System With ACTIVE Wire in Coronary CTOs.
The objective of this study is to evaluate the safety and efficacy of the SoundBite™ Crossing System - Coronary (SCS-C) in a subject population with chronic coronary artery disease including Chronic Total Occlusion (CTO).
- Trial name
- ACTIVE (NCT03521804)
- Testing
- SoundBite™ Crossing System Active Wire 14
- Where
- 5 sites in United States, Canada
- Volunteers
- 35 people
- Sponsor
- SoundBite Medical Solutions, Inc.
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III All-comers Orsiro Safety and Performance Registry
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
- Trial name
- BIOFLOW-III (NCT01553526)
- Where
- 43 sites in Austria, Chile and 11 more
- Volunteers
- 1,356 people
- Sponsor
- Biotronik AG
Chronic Total Occlusion of Coronary Artery
A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter
This is a prospective, non-randomized, first-in-man investigational study, to assess the safety and technical feasibility, deployment and withdrawal characteristics of the NovaCross™ micro-catheter during an interventional…
- Trial name
- NCT01978860
- Testing
- NovaCross, CTO
- Where
- Israel
- Volunteers
- 2 people
- Sponsor
- Chanan Schneider
Chronic Total Occlusion, Ischemic Heart Disease
Chronic Total Occlusion Percutaneous Coronary Intervention Study
The objective of this study is to evaluate angiographic confirmation of placement of any guidewire beyond the CTO, in the true vessel lumen, in patients undergoing CTO percutaneous coronary intervention (PCI) in which at least…
- Conditions
- Chronic Total Occlusion, Ischemic Heart Disease, Chronic Total Occlusion of Coronary Artery
- Trial name
- CTO-PCI (NCT03988166)
- Testing
- Chronic Total Occlusion Revascularization, GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter
- Where
- 13 sites in United States
- Volunteers
- 150 people
- Sponsor
- Vascular Solutions LLC
Chronic Total Occlusion of Coronary Artery, Chronic Angina
VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions
The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.
- Trial name
- VST100 (NCT06193954)
- Testing
- VasoStar guidewire system
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- VasoStar, LLC
Coronary Artery Diseases
BIOFLOW-III VIP Russia Registry Orsiro Stent System
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the patient's body…
- Trial name
- NCT02247492
- Where
- 7 sites in Russia
- Volunteers
- 200 people
- Sponsor
- Biotronik Russia
Ischemic Heart Disease
Study to Evaluate the Safety and Effectiveness of the Biosensors Microcatheter in Coronary Chronic Total Occlusions (CTO) - BIOMICS
Biosensors, the Sponsor would like to determine if the Biosensors Microcatheter is safe and effective in treating patients with CTO by assessing a composite of in-hospital cardiac death or myocardial infarction and device success…
- Trial name
- BIOMICS (NCT04966273)
- Testing
- Microcatheter
- Where
- 9 sites in United Kingdom
- Volunteers
- 101 people
- Sponsor
- Biosensors Europe SA
Heart Failure, Chronic Heart Failure
Wearable Tissue Oximetry During Arm Cuff Occlusion, Walking, and Standing Tests in Outpatients With Chronic Heart Failure
This prospective, single-center, observational pilot study evaluated an investigational wearable tissue oximeter (NIRSense Argus Oximetry System, also called Envello Core) in adult outpatients with chronic heart failure in New…
- Trial name
- NCT07874386
- Testing
- Argus Oximetry System
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- NIRSense Inc.
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Austria Satellite Registry
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
- Trial name
- NCT01667016
- Where
- 8 sites in Austria
- Volunteers
- 305 people
- Sponsor
- Biotronik Vertriebs-GmbH
Coronary Chronic Total Occlusion
Study to Evaluate the Safety and Efficacy of the CiTop™ ExPander™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
A multicenter multinational study to evaluate the safety and efficacy of the CiTop™ ExPander™ Guidewire for crossing chronic total occlusion in Coronary arteries.
- Trial name
- NCT00733070
- Testing
- CiTop™ ExPander™ Guidewire
- Where
- 3 sites in Germany, South Africa
- Volunteers
- 30 people
- Sponsor
- Ovalum
Coronary Occlusion
Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter
This study will include up to 60 eligible male and female subjects. The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total…
- Trial name
- NCT03717675
- Testing
- NovaCross™ Chronic Total Occlusion micro-catheter
- Where
- 3 sites in Israel, Poland and 1 more
- Volunteers
- 40 people
- Sponsor
- Nitiloop Ltd.
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW III Asia Registry Orsiro Stent System
Cliflical evaluation of th' Orsiro LESS 10 diabetic subjects requiring coronary revasculariza t ion with Drug Eluting Stefl ts (DES) .880 subjects will be enrolled in this registry.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Diabetes Mellitus Type 1 or 2
- Trial name
- NCT01941290
- Where
- 19 sites in China, India and 3 more
- Volunteers
- 387 people
- Sponsor
- BIOTRONIK Asia Pacific Pte Ltd
Drug-Eluting Stents, Percutaneous Coronary Intervention
Firehawk™ Coronary Stent System in the Treatment of Coronary Chronic Total Occlusion Lesion(s)
This study is a prospective, multi-center, open-label, randomized controlled clinical trial,aims to assess the safety and effectiveness of the Firehawk™ sirolimus target-eluting coronary stent system with abluminal grooves…
- Conditions
- Drug-Eluting Stents, Percutaneous Coronary Intervention, Tomography, Optical Coherence
- Trial name
- NCT03040934
- Testing
- Firehawk sirolimus target eluting coronary stent system, XIENCE Everolimus-Eluting Coronary Stent System
- Where
- China
- Volunteers
- 196 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Coronary Artery Disease
PowerAssert Radio-Frequency (RF) Guidewire Coronary In-Stent Chronic Total Occlusion (CTO)
A single center Pilot Clinical Registry Study of the" Acute Procedural" Safety and Efficacy of Stereotaxis PowerAssert(TM)RF Coronary Total Occlusion System assisted Angioplasty in the Treatment of Refractory Coronary Total…
- Trial name
- TOTAR (NCT01131793)
- Testing
- PowerAssert RF wire in crossing coronary in-stent chronic total occlusions
- Where
- Netherlands
- Volunteers
- 5 people
- Sponsor
- Stereotaxis
Chronic Total Occlusion of Coronary Artery
To Evaluate Whether IVUS-guided Drug-eluting Stent (DES) Implantation Leads to Better Clinical Outcomes Compared to Conventional Angiography in the Treatment of Chronic Complete Occlusion (CTO) Disease.
This study aims to evaluate the treatment of Chronic total occlusion (CTO) disease. Whether Intravascular Ultrasonography (IVUS) guiding the implantation of drug-eluting stents (DES) will provide better long-term clinical…
- Trial name
- CRUISE-CTO (NCT04944615)
- Testing
- The guidewire successfully passed the CTO lesion
- Where
- China
- Volunteers
- 1,448 people
- Sponsor
- CCRF Inc., Beijing, China
Coronary Artery Disease, Coronary Artery Chronic Total Occlusion
CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) Study
This study is to determine if the BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire) can facilitate safe and effective placement of a guidewire in the true lumen of coronary vessels distal to a…
- Trial name
- NCT00801710
- Testing
- BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)
- Where
- 4 sites in Germany
- Volunteers
- 42 people
- Sponsor
- Boston Scientific Corporation
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