Chronic Total Occlusion Clinical Trial
Official title:
A Prospective, Single Center, Non-randomized, Single Arm, Open Label, Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
Verified date | September 2016 |
Source | Nitiloop Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | September 17, 2017 |
Est. primary completion date | September 17, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 80 Years |
Eligibility | Inclusion Criteria: - Adult aged 25-80 - Patient understands and has signed the study informed consent form. - Patient is a suitable candidate for non-emergent, coronary angioplasty - Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration either by documentation or PI assessment Investigator) showing distal TIMI flow 0. - Coronary angiography of CTO lesion reveals satisfactory distal vessel visualization - CTO lesion is located in a coronary vessel with a reference diameter of at least 2 millimeters. - CTO lesion is suitable for antegrade approach. - Left ventricle ejection fraction > 25% - Body Mass Index (BMI) < 40 Exclusion Criteria: - Patient unable to give informed consent. - Patient is participating in another study with any investigational drug or device. - Patient is known or suspected not to tolerate the contrast agent. - Aorto-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO. - Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor). - Appearance of a fresh thrombus or intraluminal filling defects. - Recent major cerebrovascular event (stroke or TIA within 30 days) - Significant anemia (hemoglobin < 8.0 mg / dl) - Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) - Recent myocardial infarction (MI) (within the past two weeks) - Unwillingness or inability to comply with any protocol requirements - Pregnancy or nursing |
Country | Name | City | State |
---|---|---|---|
Poland | Szpital Uniwersytecki w Krakowie | Kraków |
Lead Sponsor | Collaborator |
---|---|
Nitiloop Ltd. |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiovascular Adverse Events (Primary Safety) | Accumulative incidence of Major Adverse Cardiovascular Events (MACE), defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)). | 30 days | |
Primary | Technical Success (Primary Efficacy) | Intra-procedural technical success, defined as the ability of the NovaCross™ microcatheter to successfully facilitate placement of a guidewire beyond a native coronary chronic total occlusion in the true vessel lumen | 1 day | |
Secondary | Procedural Success | The ability to cross the lesion with a guidewire in the true lumen, effectively dilate the CTO lesion, and place a coronary stent with residual lumen stenosis of less than 30% while restoring antegrade TIMI 3 flow | 1 day | |
Secondary | Assistance in Guidewire Penetration | The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO | 1 day | |
Secondary | Crossability | The effectiveness of the extendable portion in intra-CTO microcatheter crossability | 1 day | |
Secondary | Procedual Visualization | The ability to have full visualization of the NovaCross during the CTO procedure | 1 day | |
Secondary | Operator Ease of Use | Assess the usability of the NovaCross™ by the operator | 1 day | |
Secondary | Device Related Perforation Rate | Device-related perforation at the site of target coronary lesion and/or its proximal reference segment | 1 day |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05111496 -
Evaluation of the Radiological Dose Delivered to Risky Interventional Cardiology Patients (Optidose)
|
||
Not yet recruiting |
NCT05440084 -
Impact of CTO PCI (Chronic Total Occlusion Percutaneous Intervention) on Regular Physical Activity
|
||
Withdrawn |
NCT04059536 -
Registry Study to Evaluate the Performance and Safety of Roxwood Medical Catheters in Arteries of Participants With a Stenotic Lesion or Chronic Total Occlusion (CTO)
|
||
Completed |
NCT05158686 -
Use of Drug-Coated Balloon to Improve Recanalization of a Coronary Chronic Total Occlusion After Failed Angioplasty
|
||
Completed |
NCT03988166 -
Chronic Total Occlusion Percutaneous Coronary Intervention Study
|
N/A | |
Not yet recruiting |
NCT06175377 -
Antiplatelet Therapy After Successful Percutaneous Coronary Intervention for Chronically Occluded Coronary Artery
|
N/A | |
Not yet recruiting |
NCT05632653 -
CTO-PCI in Heart Failure Patients
|
N/A | |
Recruiting |
NCT03563989 -
STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion
|
N/A | |
Recruiting |
NCT04710342 -
Clinical Study Evaluating Use of the CapBuster Medical Device System for the Crossing of Chronic Total Occlusions
|
N/A | |
Not yet recruiting |
NCT06358508 -
Sapphire 3 CTO Study
|
N/A | |
Completed |
NCT01246505 -
Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions
|
Phase 3 | |
Recruiting |
NCT05614180 -
Chronic Total Occlusive Lesions CMR Study
|
||
Completed |
NCT04226326 -
Investigating the Utility of Remote Index of Microvascular Resistance in Patients With Chronic Total Occlusion
|
N/A | |
Recruiting |
NCT04533633 -
German Epicardial Collateral CTO Registry
|
||
Recruiting |
NCT04650139 -
Coronary Interventions Ulm - Coronary Chronic Total Occlusions
|
||
Recruiting |
NCT06137521 -
Risk Factors and Outcomes in Coronary Chronic Total Occlusion
|
||
Completed |
NCT02358629 -
A Prospective, Non-randomized Study to Evaluate the Safety and Performance of the NovaCross™ Microcatheter in Femoropopliteal Chronic Total Occlusion (CTO).
|
N/A | |
Completed |
NCT00670436 -
The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions
|
Phase 2 | |
Active, not recruiting |
NCT02227771 -
Consistent CTO Trial
|
N/A | |
Recruiting |
NCT05458999 -
Decreasing Patient Anxiety During Revascularization of Chronic Total Coronary Occlusions Using Virtual Reality Glasses.
|
N/A |