Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-02-27 @ 4:06 PM
Study NCT ID:
NCT02784405
Status:
UNKNOWN
Last Update Posted:
2016-12-19
First Post:
2016-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-apposing Stentys Stents Registry
Sponsor:
A.O.U. Città della Salute e della Scienza
Organization:
Study Overview
Official Title:
Safety and Effectiveness of the Self-aPposing, bAlloon-delivered, dRug-eluting Stent for the Treatment of the Coronary Artery Disease: A multiCenter Registry
Status:
UNKNOWN
Status Verified Date:
2016-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARTA
Brief Summary:
Self-apposing, drug-eluting Stentys coronary stents represent a valuable tool for the treatment of coronary artery stenosis. Their ability to adapt to widely varying vessel calibers and to auto-expand after their release to self-appose to vessel walls is particularly useful in the presence of ectasic coronary arteries or significant vessel tapering. The investigators planned this study to assess the feasibility, the effectiveness and the safety of the implantation of self-apposing, drug-eluting Stentys stents for percutaneous coronary intervention.
Consecutive patients undergoing percutaneous coronary intervention with implantation of a self-apposing Stentys stent were enrolled in this multi center registry. Inclusion criteria were age ≥ 18 years and ability to provide informed consent. No exclusion criteria were defined.
Primary end-point of the study is the occurrence of MACE (death, myocardial infarction, stent thrombosis, unplanned hospitalization for unstable angina, target lesion revascularization). Secondary end-points include individual components of MACE, procedural complications (periprocedural MI, bleedings, access site complication, failure to cross stent struts with guidewire in the treatment of bifurcation, failure to delivery the stent, contrast-induced nephropathy), bleedings at follow up.
Consecutive patients undergoing percutaneous coronary intervention with implantation of a self-apposing Stentys stent were enrolled in this multi center registry. Inclusion criteria were age ≥ 18 years and ability to provide informed consent. No exclusion criteria were defined.
Primary end-point of the study is the occurrence of MACE (death, myocardial infarction, stent thrombosis, unplanned hospitalization for unstable angina, target lesion revascularization). Secondary end-points include individual components of MACE, procedural complications (periprocedural MI, bleedings, access site complication, failure to cross stent struts with guidewire in the treatment of bifurcation, failure to delivery the stent, contrast-induced nephropathy), bleedings at follow up.
Detailed Description:
Rationale: Choice of the appropriate size of stents in the treatment of coronary artery stenosis can often be challenging. Marked tapering of vessels' diameter in their proximal-distal development may lead to sub-optimal results. Distal under-expansion of the drug-eluting stent (DES) or vessel perforation may occur if a larger DES, best suited for the proximal diameter, is chosen. Proximal DES under-sizing with struts malapposition may happen if a smaller DES, fitting the distal diameter, is implanted. Moreover, ectasic vessels present irregular and varying diameter, which may lead as well to segmental malapposition or under-expansion of DES. Self-apposing stents can overcome these limitations thanks to their ability to self-expand also after their release in the vessel and to adapt to a wide range of vessel diameters. Multiple generation of self-apposing, drug-eluting stents have been developed, with progressive amendments pertaining the stent-deployment technique (from deployment by covering-sheath retraction to balloon-delivery) and the drug released (from paclitaxel to sirolimus). The last generation of the self-apposing stents is represented by the sirolimus-eluting, balloon-delivered Xposition S stents. Studies assessing performance of this stent are however limited in sample size and length of follow up, and are mainly controlled trials. Few data are available regarding the clinical outcomes of the self-apposing Stentys stents in a "real-life" setting.
Aim of this study is to assess the feasibility, the effectiveness and the safety of the implantation of self-apposing, drug-eluting Stentys stents for percutaneous coronary intervention.
Study population: Patients undergoing percutaneous coronary intervention with implantation of a self-apposing Stentys stent.
Primary analysis: Longitudinal cohort follow up
Study end-points:
Primary efficacy end-point:
* Major adverse cardiovascular events (MACE) (a composite end point including death, myocardial infarction (MI, excluding periprocedural MI), stent thrombosis, unplanned hospitalization for unstable angina, target lesion revascularization (TLR))
Secondary efficacy end-points:
* Individual components of MACE (death, MI, stent thrombosis, unplanned hospitalization, TLR)
Secondary safety end-points:
* Procedural complications:
* Periprocedural MI
* Bleedings
* Access site complication
* Failure to cross stent struts with guidewire in the treatment of bifurcation
* Failure to delivery the stent
* Contrast-induced nephropathy
* Bleedings at follow up
Aim of this study is to assess the feasibility, the effectiveness and the safety of the implantation of self-apposing, drug-eluting Stentys stents for percutaneous coronary intervention.
Study population: Patients undergoing percutaneous coronary intervention with implantation of a self-apposing Stentys stent.
Primary analysis: Longitudinal cohort follow up
Study end-points:
Primary efficacy end-point:
* Major adverse cardiovascular events (MACE) (a composite end point including death, myocardial infarction (MI, excluding periprocedural MI), stent thrombosis, unplanned hospitalization for unstable angina, target lesion revascularization (TLR))
Secondary efficacy end-points:
* Individual components of MACE (death, MI, stent thrombosis, unplanned hospitalization, TLR)
Secondary safety end-points:
* Procedural complications:
* Periprocedural MI
* Bleedings
* Access site complication
* Failure to cross stent struts with guidewire in the treatment of bifurcation
* Failure to delivery the stent
* Contrast-induced nephropathy
* Bleedings at follow up
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: