Clinical trials: Chronic Total Occlusion (CTO)
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 Hungary 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
- NCT01892917
- Where
- 13 sites in Hungary
- Volunteers
- 2,000 people
- Sponsor
- Biotronik Hungária Kft.
Coronary Occlusion
Cohort B of the Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter
A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary…
- Trial name
- NCT03719014
- Testing
- NovaCross
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Nitiloop Ltd.
Coronary Artery Diseases
BIOFLOW III Satellite-Italy Orsiro Stent System
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry.
- Trial name
- NCT02028728
- Where
- 18 sites in Italy
- Volunteers
- 609 people
- Sponsor
- Biotronik Italia S.p.A.
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Belgium 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
- NCT01831336
- Where
- 8 sites in Belgium
- Volunteers
- 332 people
- Sponsor
- Biotronik Belgium NV
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
Peripheral Arterial Occlusive Disease, Chronic Total Occlusion of Artery of the Extremities
Prospective Study of the SoundBite™ Crossing System in Complex Peripheral CTOs
This study aims at assessing additional performance characteristics of the SoundBite™ Crossing System with regards to the luminal passage of complex Chronic Total Occlusions (CTO) by evaluating clinically relevant efficacy…
- Trial name
- PROSPECTORII (NCT03933657)
- Testing
- SoundBite™ Crossing System - Peripheral
- Where
- 2 sites in Austria, Germany
- Sponsor
- SoundBite Medical Solutions, Inc.
Chronic Total Occlusion of Coronary Artery
A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
This study evaluates the safety and effectiveness of the a novel device called NovaCross to help cross Chronic Total Occlusion (CTO) lesions in coronary arteries.
- Trial name
- NCT02477579
- Testing
- NovaCross
- Where
- 5 sites in United States, Poland
- Volunteers
- 145 people
- Sponsor
- Nitiloop Ltd.
Coronary Artery Disease Obliterative, Chronic Total Occlusion (CTO)
A Prospective, Non-Randomized Pivotal Clinical Investigation to Demonstrate the Safety and Performance of the TrueCross Single-Use Microcatheter
The trial is a pivotal clinical investigation, which is a prospective, non-randomized pivotal clinical investigation to demonstrate the safety and performance of the TrueCross Single-use Microcatheter.
- Trial name
- NCT06030271
- Testing
- Microcatheter
- Where
- 7 sites in Georgia, Greece and 1 more
- Volunteers
- 60 people
- Sponsor
- Insight Lifetech Co., Ltd.
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 Artery of the Extremities
Crosser Enters The Right Arterial Lumen
The purpose of this study is to determine if the CROSSER CTO Recanalization System can facilitate the successful crossing of Chronic Total Occlusions in the Central lumen of the Superficial Femoral Artery (SFA).
- Trial name
- CENTRAL (NCT01205386)
- Testing
- 1. CROSSER System
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- C. R. Bard
Chronic Total Occlusion
A Single Center Study to Evaluate the Safety of the NovaCross Microcatheter in Crossing Chronic Total Occlusions
This is an open label, single-center, prospective, pivotal study in which the investigational device, NovaCross™ micro-catheter, will be tested in up to 15 patients scheduled to undergo CTO-PCI using an anterograde approach.
- Trial name
- NCT04862559
- Testing
- NovaCross
- Where
- Poland
- Volunteers
- 15 people
- Sponsor
- Nitiloop Ltd.
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
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
Peripheral Artery Disease
Soundbite Crossing System Peripheral First in Man
This is a clinical study aimed at demonstrating the safety and product performance of the SoundBite Crossing System. The study shall demonstrate that the SoundBite Crossing System can facilitate passage of a standard guidewire…
- Trial name
- NCT03013088
- Testing
- CTO Crossing
- Where
- 2 sites in Canada
- Volunteers
- 37 people
- Sponsor
- SoundBite Medical Solutions, Inc.
Catheterization, Peripheral
Safety & Performance Randomized Study of the CiTop™ Guidewire for Peripheral CTO
The main objectives of the study are: To evaluate the performance and safety of the CiTop guidewire, while attempting to cross thru total occlusions of various dimensions and morphology.
- Trial name
- NCT00482742
- Testing
- CiTop(TM) Guidewire
- Where
- 3 sites in Croatia, Israel
- Volunteers
- 50 people
- Sponsor
- Ovalum
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Romania 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
- NCT01593059
- Where
- 4 sites in Romania
- Volunteers
- 13 people
- Sponsor
- Biotronik Vertriebs-GmbH
Femoropopliteal Occlusive Disease
Accessing Peripheral Occluded LesiOns II (APOLO-II)
The current study is a prospective, single-arm, non-randomized, multi-center study to evaluate the outcome of the ENABLER-P Catheter System for crossing chronic total occlusions during endovascular intervention for…
- Trial name
- APOLO-II (NCT01884701)
- Testing
- ENABLER-P Catheter System
- Sponsor
- EndoCross Ltd.
Coronary Artery Chronic Total Occlusion
Facilitated Antegrade Steering Technique in Chronic Total Occlusions (FAST-CTOs)
Prospective, non-randomized, multicenter study in subjects with coronary artery chronic total occlusions (CTOs). Published results of safety and effectiveness of conventional techniques will be used for comparison.
- Trial name
- FAST-CTOs (NCT00886899)
- Testing
- Recanalization of a coronary chronic total occlusion
- Where
- 16 sites in United States
- Volunteers
- 147 people
- Sponsor
- BridgePoint Medical
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