Clinical trials: Chronic Total Occlusion
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
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 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
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
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
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 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
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
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
Chronic Total Occlusion
Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries
Study of the OffRoad™ Re-entry Catheter System for subintimal recanalization of chronic total occlusions in native femoropopliteal arteries.
- Trial name
- Re-ROUTE (NCT01500031)
- Testing
- OffRoad Re-entry Catheter System
- Volunteers
- 92 people
- Sponsor
- Boston Scientific Corporation
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, 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 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 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
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
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.
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.
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
Chronic Total Occlusion of Arteries of the Extremities
SoundBite™ Crossing System Pivotal Peripheral CTO Crossing Study
This study is aimed at demonstrating the efficacy and safety of the SoundBite™ Crossing System-Peripheral. The study is intended to demonstrate that the SoundBite™ Crossing System can facilitate the passage of either devices…
- Trial name
- PROSPECTOR (NCT03266835)
- Testing
- SoundBite™ Crossing System - Peripheral
- Where
- 2 sites in United States, Canada
- Volunteers
- 15 people
- Sponsor
- SoundBite Medical Solutions, Inc.