Clinical trials: Chronic Total Coronary Occlusions
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 Occlusion
Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
The CiTop™ guidewire Coronary study is a feasibility open label study, to evaluate the safety and efficacy of the CiTop™ Guidewire for crossing chronic total occlusion in Coronary arteries.
- Trial name
- NCT00618020
- Testing
- CiTop(tm) Guidewire
- Where
- India
- Volunteers
- 10 people
- Sponsor
- Ovalum
Chronic Total Occlusion of Coronary Artery, Coronary Occlusion
ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.
ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to: Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable…
- Conditions
- Chronic Total Occlusion of Coronary Artery, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Restenosis
- Trial name
- NCT01759290
- Testing
- Absorb Bioresorbable Vascular Scaffold
- Where
- Belgium
- Volunteers
- 1,800 people
- Sponsor
- Abbott Medical Devices
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 (CAD), Chronic Total Occlusion (CTO)
EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions
A prospective, multi-center, single-arm study to establish the safety and effectiveness of the XIENCE V® Everolimus Eluting Coronary Stent, XIENCE nano™ Everolimus Eluting Coronary Stent, XIENCE PRIME™ LL Everolimus Eluting…
- Trial name
- EXPERT CTO (NCT01435031)
- Testing
- CTO Treatment Device
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Diseases
BIOTRONIK - BIOFLOW-III Registry French Satellite
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success.
- Trial name
- NCT02273648
- Testing
- Drug Eluting Stent (DES)
- Where
- 50 sites in France
- Volunteers
- 1,000 people
- Sponsor
- Biotronik France
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Canada Satellite Registry
For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success.
- Trial name
- NCT01880242
- Where
- 2 sites in Canada
- Volunteers
- 250 people
- Sponsor
- Biotronik Canada Inc
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Israel Satellite Registry
BIOTRONIK - SaFety and Performance Registry for a diabetic patient population with the .bimus Eluting Orsiro Stent System Within daily clinical practice - III
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Diabetes Mellitus Type 1 or 2
- Trial name
- NCT01895712
- Where
- 6 sites in Israel
- Volunteers
- 120 people
- Sponsor
- BIOTRONIK Israel
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
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 of Coronary Artery
Evaluating the Use of the CapBuster System for the Crossing of CTO's in Coronary Arteries
Evaluate the safety and effectiveness of the CapBuster System medical device in crossing de novo or restenotic chronic total occlusions in coronary arteries
- Trial name
- NCT05733481
- Testing
- CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary Arteries
- Volunteers
- 26 people
- Sponsor
- Praxis Medical Devices 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
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.
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.
CAD
Trial for A Novel Facilitated Antegrade Steering Technique in Revascularization of Coronary Chronic Total Occlusions
To assess the safety and efficacy of the BridgePoint CTO system in recanalization of CTO lesions which are resistant to a conventional wire approach in a multicenter study in Chinese population
- Trial name
- NCT03901079
- Testing
- single-arm study
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
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.
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.
Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery
Cardiac Cath Lab Staff Radiation Exposure
The objective of this randomized safety and observational study is to demonstrate CorPath GRX chronic total occlusion PCI is safe, and that Cardiac Catheterization Laboratory staff have no additional exposure to radiation when…
- Conditions
- Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Percutaneous Coronary Intervention
- Trial name
- SAFE-T (NCT03959072)
- Testing
- Robotic CTO PCI, Conventional (Manual) CTO PCI
- Where
- 3 sites in United States
- Volunteers
- 74 people
- Sponsor
- Siemens Healthineers Endovascular Robotics, Inc.
Coronary Chronic Total Occlusions, Ischemic Heart Disease
Acolyte CTO-PCI Study: Imaging and Catheter System to Treat Patients With Coronary Chronic Total Occlusion, Who Have Persistent Symptoms Following Medical Therapy and Are Undergoing Percutaneous Coronary Interventional Procedures
This is a study to evaluate the safety and effectiveness of the Acolyte Catheter System used in CTO-PCI procedures. The system will be used for the placement and positioning of guidewires and catheters in the coronary vasculature…
- Conditions
- Coronary Chronic Total Occlusions, Ischemic Heart Disease, Ischemic Heart Disease (IHD), Ischemic Heart Disease Chronic
- Trial name
- NCT06795763
- Testing
- CTO-PCI Procedure with Acolyte Catheter System
- Where
- 5 sites in United States
- Volunteers
- 115 people
- Sponsor
- Elumn8 Medical
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