Self-exPAndable Coronary stentIng in subacute and chrOnic total occlusions; a pilot study

Completed

Conditions: Coronary artery Chronic Total Occlusion
Coronary chronic occlusion
10011082

Registration Number: NL-OMON40524

Lead Sponsor: Albert Schweitzer Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

1. Patient with a total or subtotal occlusion as evidenced by angiography and under optimal drug regimen amenable for revascularization.
2. Subject >=18 years.
3. Reference vessel diameter >=2.5mm and <=6mm preferably measured by QCA, or if QCA not possible by visual estimate.
4. Subject understands the nature of the procedure and provides written informed consent prior to the procedure.
5. Subject is willing to comply with specified follow-up evaluation and can be contacted by telephone

Exclusion Criteria

1. Acute coronary syndromes, but not post-infarction AP
2. Cardiogenic shock.
3. Any vasculature lesions or characteristics preventing PCI, introduction of the STENTYS delivery system or placement of the STENTYS Stent.
4. Allergies or contraindications to antiplatelet medication, contrast or to stent components which cannot be adequately treated.
5. Female patient with child bearing potential not taking adequate contraceptives.
6. Participation in another investigational drug or device study in which the primary endpoint has not been reached yet and that interferes with this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint will be mean lumen area gain at 4-6 weeks follow-up,<br /><br>measured by OCT. We hypothesize that this gain will be similar to the average<br /><br>11.5% gain found in Apposition II, evaluated the STENTYS BMS with OCT after<br /><br>implantation for a STEMI.</p><br>

Secondary Outcome Measures