Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02477579
Other study ID # NT-CLP-01
Secondary ID
Status Completed
Phase N/A
First received June 17, 2015
Last updated August 14, 2017
Start date May 17, 2015
Est. completion date August 10, 2017

Study information

Verified date August 2017
Source Nitiloop Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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 Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt.


Recruitment information / eligibility

Status Completed
Enrollment 145
Est. completion date August 10, 2017
Est. primary completion date August 10, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Adult aged 25-80

- Patient understands and has signed the study informed consent form.

- Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration) showing distal TIMI flow 0.

- Suitable candidate for non-emergent, coronary angioplasty

- Documented coronary angiography preceding the PCI reveals at least one CTO lesion situated in a non-infarct related coronary artery or its side branches

- Body Mass Index (BMI) < 40

- Left ventricle ejection fraction > 25%

Exclusion Criteria:

- Patient unable to give informed consent.

- Current participation in another study with any investigational drug or device.

- Patient is known or suspected not to tolerate the contrast agent.

- Aorta-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO, in-stent 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 (history of stroke or TIA within 1 month)

- Cardiac intervention within 4 weeks of the procedure

- Renal insufficiency (serum creatinine of > 2.3mg/dl or 203µmol/L)

- Active gastrointestinal bleeding

- Active infection or fever that may be due to infection

- Life expectancy < 2 years due to other illnesses

- Significant anemia (hemoglobin < 8.0 mg / dl)

- Severe uncontrolled systemic hypertension (> 240 mmHg within 1 month of procedure)

- Severe electrolyte imbalance

- Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV.

- 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)

- Uncontrolled diabetes >2 serum glucose concentrations of >350 mg/dl within 7 days.

- Unwillingness or inability to comply with any protocol requirements

- Pregnant or nursing

- Extensive prior dissection from a coronary guidewire use

- Drug abuse or alcoholism.

- Patients under custodial care.

- Bleeding diathesis or coagulation disorder;

- Kawasaki's disease or other vasculitis

Study Design


Related Conditions & MeSH terms

  • Chronic Total Occlusion of Coronary Artery

Intervention

Device:
NovaCross
The NovaCross™ is a guidewire positioning and support microcatheter for improving chronic total occlusion (CTO) crossability. The NovaCross™ gains its supportive characteristics through the use of a unique operator-controlled Nitinol scaffold and an extendable segment, both at its distal tip.

Locations

Country Name City State
Poland SPZOZ University Hospital in Krakow Krakow
United States Central Arkansas Veterans Healthcare System Little Rock Arkansas
United States Edward Hospital Naperville Illinois
United States Columbia University Medical Center/New York Presbyterian Hospital New York New York
United States York Hospital York Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Nitiloop Ltd.

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary MACE 30 day 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 Intra-procedural technical success Intra-procedural technical success, defined as the ability of the NovaCross™ micro-catheter to successfully facilitate placement of a guidewire beyond a native coronary chronic total occlusion (CTO) in the true vessel lumen. Intra-procedure
Secondary 1. 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. 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. Procedure
Secondary Proximal cap (ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO.) 2. The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO. Procedure
Secondary Effectiveness of extendable portion (effectiveness of the extendable portion in intra-CTO microcatheter crossability) 3. The effectiveness of the extendable portion in intra-CTO microcatheter crossability. Procedure
Secondary Visualization (ability to have full visualization of the NovaCross during the CTO procedure) 4. The ability to have full visualization of the NovaCross during the CTO procedure. Procedure
Secondary Usability (Assess the usability of the NovaCross™ by the operator) 5. Assess the usability of the NovaCross™ by the operator. Procedure
Secondary Device-related perforation (at the site of target coronary lesion and/or its proximal reference segment) 6. Device-related perforation at the site of target coronary lesion and/or its proximal reference segment. Procedure
See also
  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 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
Terminated NCT03118544 - REduction of Contrast Via DyeVert Used in CTO Procedures