Study to Evaluate the Safety and Efficacy of the CiTop™ ExPander™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries

Study Overview
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Brief Summary
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A multicenter multinational study to evaluate the safety and efficacy of the CiTop™ ExPander™ Guidewire for crossing chronic total occlusion in Coronary arteries.

Official Title
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A Multicenter Multinational Study to Evaluate the Safety and Efficacy of the CiTop™ ExPander™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries

Conditions
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Coronary Chronic Total Occlusion

Intervention / Treatment
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* Device: CiTop™ ExPander™ Guidewire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent obtained prior to any trial activities. Patients, male or female between 21 and 80 years of age, with no significant co-morbidities (see exclusion criteria). Patient has an angiographic documented Chronic Total Occlusion showing distal TIMI flow 0 to 1. Exclusion Criteria: Patient unable to give informed consent. Current participation in another study with any investigational drug or device. Factors making follow-up and/or repeat angiography difficult or unlikely. Contra-indication to emergency artery by pass surgery. Lack of surgical backup. Contra-indication to treatment with Aspirin, or Clopidogrel and/or Heparin. Lesion > 40mm in length (both calcified lesion and adjacent thrombus). Treated vessel referenced diameter less than 2.5 mm. Visualization of the distal lumen less than the Rentrop Classification Grade 2 collateralization. Non-visible entry point of target lesion. Totally occluded bypass graft as target vessel. Acute MI less than 1 week before procedure. Patient has significant LV dysfunction, 35% LVEF or less. Patient with cancer or other sever chronic disease with life expectance of 2 years. Patient has chronic renal failure with serum creatinine ≥2. Hemoglobin ≤11. Patient is known or suspected not to tolerate the contrast agent. Morbid Obesity (BMI > 40). Drug abuse or alcoholism. Patients under custodial care. Pregnant women or women with childbearing potential with a positive pregnancy test at the time of procedure.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CiTop™ ExPander™ Guidewire|Chronic Total Occlusion guidewire|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications |  | during procedure, 1day, 1week and 30 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful stenting |  | During procedure, Day1, Day7 and Day30 post procedure | 
| Wire crossing duration |  | during procedure | 
| Fluoroscopy time |  | during procedure | 
| Amount of contrast |  | during procedure | 
| Maneuverability of the CiTop™ up to the occlusion |  | during procedure | 
| No mechanical damage to the device during |  | during procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTO, Chronic Total Occlusion, Revascularization