Clinical trials: Chronic Total Occlusions
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 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
Peripheral Arterial Disease
Evaluating Plaque Photoablation Using an Excimer Laser in Patients With Lower Extremity Vascular Disease
The purpose of this study is to evaluate the safety and efficacy of an excimer laser in the treatment of patients with lower extremity vascular disease with chronic total occlusions.
- Trial name
- NCT02653456
- Testing
- RA-308 Excimer Laser and DABRA Catheter
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- Ra Medical Systems
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 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
Coronary Artery Diseases
BIOFLOW-III UK Satellite Registry 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
- NCT02257710
- Testing
- Orsiro
- Where
- 4 sites in United Kingdom
- Volunteers
- 500 people
- Sponsor
- Biotronik UK Ltd.
Critical Limb Ischemia, Peripheral Arterial Disease
IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA
To assess the safety and efficacy of the paclitaxel drug-coated balloon IN.PACT 014 versus conventional optimal percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the…
- Trial name
- NCT02963649
- Testing
- DCB, PTA
- Where
- 9 sites in Belgium, France and 3 more
- Volunteers
- 50 people
- Sponsor
- Medtronic Endovascular
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.
Chronic Total Occlusion
Clinical Study Evaluating Use of the CapBuster Medical Device System for the Crossing of Chronic Total Occlusions
This study represents a prospective, non-randomized, dual-center clinical study to evaluate the safety and effectiveness of the CapBuster System in crossing a de novo or restenotic infrapopliteal chronic total occlusion.
- Trial name
- CapBuster (NCT04710342)
- Testing
- CapBuster
- Where
- Netherlands
- Volunteers
- 26 people
- Sponsor
- Praxis Medical Devices Ltd
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, 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
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.
Coronary Artery Disease, Coronary Artery Chronic Total Occlusion
The Asahi Intecc PTCA Chronic Total Occlusion Study
The primary objective of this trial is to evaluate confirmation of placement of any guidewire beyond the chronic total occlusion (CTO) in the true vessel lumen in patients in which at least one Asahi series of guidewires and/or…
- Trial name
- CTO-PCI (NCT02379923)
- Testing
- Crossing of Coronary Artery CTO
- Where
- 12 sites in United States
- Volunteers
- 163 people
- Sponsor
- Asahi Intecc USA Inc
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.
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
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