Drug-COated Balloon Coronary Angioplasty versus Stenting for Treatment of Disease Adjacent to a Chronic Total Occlusion - The Co-CTO Trial.

Phase 3

Recruiting

Conditions: arteriosclerosis
coronary artery disease
10011082

Registration Number: NL-OMON51074

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 144

Inclusion Criteria

• Age >= 18 years
• Clinical indication for revascularization of the CTO as determined by the
local heart team (based on symptoms, documented ischemia, and viability)
• Successful recanalization of the CTO with residual disease adjacent to the
initial lesion

Exclusion Criteria

• Dissection affecting the flow (TIMI score <3), significant recoil (>30%) or
coronary perforation after predilation
• Reference diameter of the vessel is <2.5 mm or >4.0 mm
• Bifurcation lesion requiring the stenting of the side branch
• Left main lesion
• Acute coronary syndrome
• Cardiogenic shock
• Severe kidney disease defined as an eGFR < 30 ml/min
• Pregnancy
• Life expectancy < 12 months
• Inability to give written consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to investigate percentage diameter stenosis at 1-year<br /><br>follow-up as assessed by intravascular ultrasound (IVUS) in patients<br /><br>successfully treated with PCI CTO randomized to stenting of the CTO body in<br /><br>conjunction with DCB of residual disease compared to stenting of residual<br /><br>disease adjacent to the CTO body.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary invasive imaging objectives are minimal lumen diameter, late luminal<br /><br>loss, in-segment binary restenosis, and target vessel re-occlusion at 1-year<br /><br>follow-up. Secondary clinical objectives are evaluation of the occurrence of<br /><br>major adverse cardiac events (MACE) at 1-year follow-up.</p><br>