Post market study to evaluate the vascular response to the Sideguard® Coronary Sidebranch Stent in de novo coronary bifurcation lesions using intravascular ultrasound (IVUS) and optical coherence tomography (OCT) Protocol ID: SG3 Revision #1 Date: 09 Sep 09

Post market study to evaluate the vascular response to the Sideguard® Coronary Sidebranch Stent in de novo coronary bifurcation lesions using intravascular ultrasound (IVUS) and optical coherence tomography (OCT) Protocol ID: SG3 Revision #1 Date: 09 Sep 09 - Sideguard 3 (SG3) IVUS OCT Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32585

Enrollment

Registered

2010-02-02

Start date

2010-03-02

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Artherosclerotic cornoray artery disease

Interventions

IVUS pre procedure, followed by implantation of Sideguard® Coronary Sidebranch Stent, followed by IVUS post procedure. Also IVUS and/or OCT will be carried out at 6 months follow up.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Above 18 years of age. 2. Significant ischemic heart disease (CCS class, Braunwald class B, C and I *II, or documented silent ischemia). 3. Treatment of a single bifurcated de novo lesion in a native vessel (Medina type 1,1,1; 1,0,1; 0,1,1). 4. Main vessel lesion in a vessel with a reference vessel diameter (RVD) of 2.8 * 4.0mm and 30 mm in length and a sidebranch lesion with a RVD of 2.25 * 3.25mm and 7mm in length (visual estimate) in patients with single or multi vessel disease. 5. Acceptable candidate for coronary intervention and coronary bypass surgery. 6. The patient has been informed about the trial, agrees to its provisions and provided written informed consent approved by the applicable committee (EC). 7. Target lesion must be

Exclusion criteria

Exclusion criteria: 1. Target lesion is a totally occluded main vessel or sidebranch. 2. Target lesion has extensive tortuosity or calcification unsuitable for stent delivery and deployment. 3. Target lesion bifurcation cannot be clearly visualized by angiography (location of ostium border line and the sidebranch angle). 4. Target lesion is located in the left main coronary artery or a RAMUS anatomy. 5. Recent myocardial infarction (either STEMI or Non-STEMI 2.0mg/dl). 9 Known allergies to aspirin, clopidogrel or ticlopidine, heparin, nitinol, *limus family of compounds*, or taxane compounds.

Design outcomes

Primary

Measure	Time frame
To determine the change in stent area (mm2) and corresponding vessel area change (mm2) at the carina of the sidebranch by IVUS assess at 6 months from the index Sideguard® stent implantation procedure.	—

Secondary

Measure	Time frame
Device success, lesion success, procedural success, angiography at 6 months, IVUS at 6 months and/or OCT at 6 months, MACE at 6 months, and stent thrombosis rate.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)