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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40524

Enrollment

Registered

2014-01-29

Start date

2014-04-02

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

Coronary artery Chronic Total Occlusion Coronary chronic occlusion

Interventions

Patients meeting all selection criteria will receive a STENTYS DES stent

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Secondary endpoints include assessment of both safety and effectiveness endpoints, specifically: 1. Major Adverse Cardiac Events (MACE): defined as cardiac death, MI, emergent bypass surgery (CABG), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at discharge, 4-6 weeks, 6 and 12 months post-procedure. 2. Target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI) [Q or Non Q-Wave], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods at discharge, 4-6 weeks, 6 and 12 months post-procedure. 3. Success Rates: 4. Device Success: Attainment of	—

Measure

Time frame

Secondary endpoints include assessment of both safety and effectiveness endpoints, specifically: 1. Major Adverse Cardiac Events (MACE): defined as cardiac death, MI, emergent bypass surgery (CABG), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at discharge, 4-6 weeks, 6 and 12 months post-procedure. 2. Target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI) [Q or Non Q-Wave], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods at discharge, 4-6 weeks, 6 and 12 months post-procedure. 3. Success Rates: 4. Device Success: Attainment of

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)