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
- Conditions
- Artherosclerotic cornoray artery disease10011082
- Registration Number
- NL-OMON32585
- Lead Sponsor
- Capella Medical devices Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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 <100% occluded by visual estimate (minimum TIMI 2 Flow)
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 < 72 hours prior to planned index procedure).
6. Angiographic evidence of occlusive thrombus.
7. Ejection fraction < 30%.
8 Impaired renal function (serum creatinine > 2.0mg/dl).
9 Known allergies to aspirin, clopidogrel or ticlopidine, heparin, nitinol, *limus family of compounds*, or taxane compounds.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the change in stent area (mm2) and corresponding vessel area<br /><br>change (mm2) at the carina of the sidebranch by IVUS assess at 6 months from<br /><br>the index Sideguard® stent implantation procedure.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Device success, lesion success, procedural success, angiography at 6 months,<br /><br>IVUS at 6 months and/or OCT at 6 months, MACE at 6 months, and stent thrombosis<br /><br>rate. </p><br>