Dual source multi-slice CT angiography for non-invasive evaluation of coronary stent patency at 6 months comparing two abluminal coated drug eluting stents: Synergy* versus Nobori*.

Completed

• Conditions: Atherosclerosis; coronaropathy; 10011082

• Registration Number: NL-OMON37096
• Lead Sponsor: Jeroen Bosch Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 128

Inclusion Criteria

1. age at least 18 years;
2. undergoing a planned elective PTCA procedure
3. signed written informed consent.

Exclusion Criteria

1. Heavily calcified lesion detected at the time of angiography;
2. Vessels with a reference lumen smaller than 2.5 mm;
3. In-Stent restenosis.
4. Bifurcation lesions requiring stenting of both main branch and side branch.
5. Patients with renal function impairment, defined as a GFR <45 mL/min.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the difference in in-stent late lumen loss at 6 months<br /><br>between the Synergy* DES and the Nobori* DES . </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. In-stent late lumen loss at 6 months detected by dual source MSCT compared<br /><br>to IVUS<br /><br>2. Stent related target vessel failure rate (cardiac death, myocardial<br /><br>infarction (MI) related to target vessel and target vessel re-intervention<br /><br>(TVR)) at 12 months post stent implantation.<br /><br>3. Stent thrombosis (ST) rate using Academic Research Consortium (ARC)<br /><br>definition (definite/probable with no censoring for Target Lesion<br /><br>Re-vascularization).<br /><br>4. Overall mortality</p><br>