Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System (DIRECT II)
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|ClinicalTrials.gov Identifier: NCT01788150|
Recruitment Status : Active, not recruiting
First Posted : February 11, 2013
Last Update Posted : April 2, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: Coronary Stenting||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||159 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||May 2019|
Experimental: Svelte Drug-Eluting Coronary Stent
|Device: Coronary Stenting|
Active Comparator: Medtronic Resolute Integrity Drug-Eluting Stent
|Device: Coronary Stenting|
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|