Clinical trials: Chronic Total Occlusion
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
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.
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
Ischemic Heart Disease, Coronary Artery Stenosis
A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions
This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention…
- Conditions
- Ischemic Heart Disease, Coronary Artery Stenosis, Chronic Coronary Total Occlusion, Coronary Bypass Graft Stenosis
- Trial name
- CROSS (NCT01186198)
- Testing
- MINI TREK RX 1.20 mm Coronary Dilatation Catheter
- Where
- 4 sites in United States
- Volunteers
- 71 people
- Sponsor
- Abbott Medical Devices
Total Atherosclerotic Occlusion of Femoral Artery
Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II
Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing totally occluded femoropopliteal arteries.
- Trial name
- CONNECTII (NCT01537302)
- Testing
- CTO crossing in femoropopliteal arteries CONNECT II
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 100 people
- Sponsor
- Avinger, 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
Chronic Total Occlusion of Artery of the Extremities
ReFlow Medical Wingman Catheter Wing-IT Clinical Trial
To evaluate the safety and effectiveness of the ReFlow Medical Wingman Catheter used to cross de novo or restenotic infrainguinal CTOs that cannot be crossed with a standard guidewire.
- Trial name
- Wing-It (NCT03403426)
- Testing
- Wingman Crossing Catheter
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- ReFlow Medical, 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, 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 Coronary Total Occlusions
Total Occlusion Study in Coronary Arteries - 5
A prospective, multi-center, double blind, 2 stage, placebo-controlled, phase II study, evaluating acute intra-coronary injected collagenase prior to routine standard-of-care percutaneous revascularization procedures in subjects…
- Trial name
- TOSCA-5 (NCT01753180)
- Testing
- collagenase, saline
- Where
- 13 sites in Canada, Israel and 1 more
- Volunteers
- 76 people
- Sponsor
- Matrizyme Pharma Corporation
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