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*.

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*. - DELICATE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37096

Enrollment

128

Registered

2012-11-05

Start date

2012-11-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis coronaropathy

Interventions

Coronary intervention with stenting.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The primary outcome is the difference in in-stent late lumen loss at 6 months between the Synergy* DES and the Nobori* DES .	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)