Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System (DIRECT II)
A prospective, randomized, active-control, multi-center clinical trial comparing the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to that of the commercially available Resolute IntegrityTM Drug-Eluting Stent.
The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting Stent in patients with single, never previously treated coronary artery lesions
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Direct Implantation of Rapamycin-Eluting Stents With Bio-Erodible Drug Carrier Technology Utilizing the Second Generation Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS)|
- Angiographic Target Vessel Failure (TVF) [ Time Frame: 6-months post-procedure ]The composite endpoint comprised of cardiac death, target vessel MI (Q or Non Q-Wave), or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.
- Angiographic in-Stent Late Lumen Loss (LL) [ Time Frame: 6-months post-procedure ]Defined as the measurements either within the stented segment or within 5 mm proximal and distal to the stent edges.
- Clinically-driven Target Lesion Revascularization (TLR) [ Time Frame: 1 and 6-months and yearly through 5-years post-procedure ]Clinically driven TLR is defined as revascularization performed on a patient who returns with clinical symptoms such as unstable angina, that is, chest pain that increases in frequency, intensity or duration.
- Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization [ Time Frame: 1 and 6-months post-procedure, and yearly up to 5-years ]Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization
- Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of non target vessels [ Time Frame: 5-years post-procedure ]Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of non target vessels
- Stent thrombosis [ Time Frame: 1 and 6-months and yearly for 5-years post-procedure ]The sudden occlusion of a stented coronary artery due to thrombus formation.
- Acute success rates [ Time Frame: From index procedure to hospital discharge ]Device Success, Direct Stenting Success, Lesion Success and procedure Success
- In-stent and in-segment angiographic binary restenosis rate [ Time Frame: 6-months post-procedure ]The rate which restenosis occurs
- In-stent and in-segment minimum lumen diameter [ Time Frame: 6-months post-procedure ]smallest diameter in the stent or segment area
- In-segment late lumen loss [ Time Frame: 6-months post-procedure ]Late lumen loss is the difference in millimeters between the diameter of a stented segment post-procedure compared with the follow-up angiogram
- Neointimal hyperplasia [ Time Frame: 6 months post procedures ](% lumen volume)
- Strut coverage [ Time Frame: 6 months post procedure ](% of struts malapposed, protruding non-covered, protruding covered, non-protruding covered)
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||May 2019|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: Svelte Drug-Eluting Coronary Stent
|Device: Coronary Stenting|
Active Comparator: Medtronic Resolute Integrity Drug-Eluting Stent
|Device: Coronary Stenting|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01788150
|OLV Ziekenhuis Aalst|
|Všeobecná fakultní nemocnice Praha|
|CHU de Toulouse|
|Medizinisches Verzorgungszentrum Prof. Mathey, Prof. Schofer|
|University Medical Center Hamburg-Eppendorf|
|Catharina Hospital Eindhoven|
|University Medical Center Utrecht, Department of Cardiology|
|Skane University Hospital|
|Principal Investigator:||Stefan Verheye, MD, PhD||Antwerp Cardiovascular Institute|
|Principal Investigator:||Alexandre Abizaid, MD, PhD||Instituto Dante Pazzanese de Cardiologia|