Chronic Total Occlusion of Coronary Artery Clinical Trial
Official title:
REgistry of CrossBoss and Hybrid Procedures in FrAnce, the NetheRlands, BelGium and UnitEd Kingdom
The successful re-opening of a blocked coronary artery has a beneficial effect on the further
clinical course (e.g. improvement of clinical symptoms, improved quality of life, increased
heart function, etc.). However, some types of blockages are more difficult to open by means
of percutaneous coronary intervention (PCI), a procedure which is commonly used for these
kind of problems. This procedure makes use of a technique in which special wires, balloons,
stents (metal or polymeric tube-like structures) and devices are utilized to re-open or
revascularize a blockage in one of the blood vessels of the heart. This type of blockages are
chronic total occlusions (CTO). CTOs have certain characteristics which impede the
revascularization of the blood vessel.
Nevertheless, remarkable progress has been achieved over the past few years in the area of
CTO revascularization or CTO PCI. A large range of CTO dedicated materials, such as
guidewires, guiding catheters, devices, balloons and stents, as well as different techniques
have been developed. However, at present, reluctance to open CTOs still exists, due to the
indications and outcomes of percutaneous revascularization as well as the technical
difficulties which commonly arise during these interventional procedures. The presence of
these difficulties results in suboptimal success rates worldwide (±70-80%), despite these
many innovations.
To increase these success rates and to make sure more interventional cardiologists will treat
CTOs, a hybrid treatment algorithm has been developed with the materials (e.g. CrossBoss™
catheter; Bridgepoint Medical, Inc.) and techniques, currently already available. The main
purpose of this study is to evaluate the efficacy and efficiency of this hybrid algorithm as
well as validating the efficacy of one of the materials (CrossBoss™ catheter), used in this
algorithm. To be able to do this, data concerning the patients' demographics, CTO
characteristics, procedure and outcome will be collected in the form of a registry. This
registry will be performed in several European centra (Belgium, the Netherlands, United
Kingdom, France). Since the study will only collect data and no intervention is performed,
this will be an observational study. At regular time points, the data will be checked for
errors or inconsistencies. To do this, site visits will be performed at pre-defined times.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
| Completed |
NCT03475888 -
Incidence of Ventricular Arrhythmias in Patients With Chronic Total Occlusion Recanalization
|
N/A | |
| Not yet recruiting |
NCT04917432 -
Early and Midterm Outcomes of Intravascular Ultrasound (IVUS) Versus Non-IVUS Guidance in Complex Coronary Chronic Total Occlusion (CTO) Revascularization.
|
N/A | |
| Recruiting |
NCT04944615 -
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.
|
N/A | |
| Completed |
NCT01861860 -
OPtimized Stenting Using Intravascular Ultrasound(IVUS) in Long lEsion: Rationale for Simplified criteriA
|
N/A | |
| Recruiting |
NCT05142215 -
A Placebo-controlled Trial of Chronic Total Occlusion Percutaneous Coronary Intervention for the Relief of Stable Angina
|
N/A | |
| Active, not recruiting |
NCT05464147 -
DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions
|
N/A | |
| Recruiting |
NCT04145167 -
Observational Registry on Clinical Outcome After Diagnosis of Chronic Total Occlusions
|
||
| Not yet recruiting |
NCT04965207 -
EvaLuAtion On the cHaracteristics of the True/False lUmen and Its Prognostic Value for cOronary CTO Patients Just Before Stent Implantation
|
||
| Active, not recruiting |
NCT05197361 -
Microvascular Coronary Resistance and Absolute Coronary FLOW in Patients With Percutaneous Intervention of a Chronic Total Occlusion
|
||
| Recruiting |
NCT05813704 -
Coronary Crossing System in Patients With Coronary Chronic Total Occlusions
|
N/A | |
| Recruiting |
NCT03563417 -
ISCHEMIA-CTO Trial - Revascularisation or Optimal Medical Therapy of CTO
|
N/A | |
| Completed |
NCT05377866 -
Holo CTO Proctoring Study
|
||
| Completed |
NCT01978860 -
A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter
|
N/A | |
| Withdrawn |
NCT02784418 -
The SHINE-CTO Trial
|
N/A | |
| Completed |
NCT03988166 -
Chronic Total Occlusion Percutaneous Coronary Intervention Study
|
N/A | |
| Completed |
NCT02477579 -
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
|
N/A | |
| Completed |
NCT03209843 -
Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure (PERFECTO)
|
N/A | |
| Completed |
NCT03947398 -
The BLIMP Balloon in Coronary Interventions
|
N/A | |
| Active, not recruiting |
NCT04060615 -
Properties of Myocardial Microcirculation in Patients With Different Pathomorphological Substrates, Before and After Recanalization of Coronary Artery CTO
|
N/A |