Effects of DES Platforms on Markers of Endothelial Damage and Inflammation (PLATFORM)
|ClinicalTrials.gov Identifier: NCT01489202|
Recruitment Status : Unknown
Verified March 2013 by Francesco Pelliccia, University of Roma La Sapienza.
Recruitment status was: Not yet recruiting
First Posted : December 9, 2011
Last Update Posted : March 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: platinum chromium everolimus-eluting stent Device: cobalt chromium everolimus-eluting stent||Phase 4|
Percutaneous coronary intervention (PCI) with stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to restenosis and atherosclerosis within the stented segments.
Drugs and polymers are considered the protagonists of these pathophysiologic processes whereas the role of stent platforms remains poorly defined.
Due to advances in stent technology, stent platforms have evolved from the cobalt-chromium (CoCr) to the platinum-chromium (PtCr) stent series. At present, the PROMUS Element stent (which uses the PtCr platform) employs an identical polymer, drug, drug formulation and dose density to the CoCr XIENCE V stent.
The PLATINUM WH trial is the only randomized trial comparing the PROMUS Element stent with the XIENCE V stent in a total of 1,530 patients. The study met its primary end-point demonstrating that the PROMUS Element stent is non-inferior to the XIENCE V stent. The 12-month rare of target lesion failure was 3.4% in the PROMUS Element stent and 2.9% in the XIENCE V stent.
Pre-clinical animal studies, however, suggest that the PtCr platform might have important advantages over the CrCo platform, as improved vascular compatibility and early and late healing for PtCr devices compared with CoCr stents have been demonstrated.
In a rabbit denudation model, it was shown that at 14 days the luminal surface area is incompletely endothelialised with the CrCo stents but nearly complete for the PtCr stents. Similarly, another experimental study has shown that overall strut coverage, including endothelial cell coverage plus non-endothelial cell coverage (focal platelet and fibrin aggregates inter-mixed with red blood cells and inflammatory cells), is significantly lower at 14 days with the CoCr stent than with the PtCr OMEGA stent. Additionally, a recent investigation has shown that the thinner-strut PtCr stent is associated with reduced fibrin deposition and more rapid fibrin clearance in porcine coronary arteries compared with CrCo stent, thus suggesting that the PtCr stent platform may induce less injury compared with previous-generation platforms.
The primary objective of this study is to perform a randomized comparison of the biohumoral effects of platinum chromium everolimus-eluting stent (PtCr EES) vs. cobalt chromium everolimus-eluting stent (CoCr EES), i.e. stents with different platforms but identical drug and polymer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Comparison of the Effects of PLatinum Chromium Everolimus-eluting Stent vs. cobAlT Chromium Everolimus-eluting Stent on inFlammatOry maRkers and Endothelial daMage - The PLATFORM Trial|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2016|
Active Comparator: platinum chromium EES
Patients undergoing PCI with stenting will have implantation of platinum chromium everolimus-eluting stents
Device: platinum chromium everolimus-eluting stent
An everolimus-eluting stent with a platinum chromium platform
Other Name: Promus ElementTM, Boston Scientific Corporation, Natick, MA, USA
Active Comparator: cobalt chromium everolimus-eluting stent
Patients undergoing PCI with stenting will have implantation of cobalt chromium everolimus-eluting stents
Device: cobalt chromium everolimus-eluting stent
An everolimus-eluting stent with cobalt chromium platform
Other Name: Xience VTM, Abbott Laboratories, Abbott Park, IL, USA
- Post-PCI changes in markers of endothelial damage [ Time Frame: Baseline and 24 hours after PCI ]
Changes 24 hours after PCI in the following indexes of endothelial damage:
- von Willebrand Factor (vWF)
- Vascular cell adhesion molecule (sVCAM-1)
- Intercellular adhesion molecule (sICAM-1)
- Post-PCI changes in markers of inflammation [ Time Frame: Baseline and 24 hours after PCI ]
Changes 24 hours after PCI in the following inflammatory markers:
- C-reactive protein (CPR)
- Plasminogen activator inhibitor (PAI-1)
- Interleukin-6 (IL-6)
- 12-month rate of MACE [ Time Frame: Up to 12 months ]12-months incidence of major adverse cardiac events (MACE—death, myocardial infarction, target vessel revascularization)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489202
|Contact: Francesco Pelliccia, MD, PhDemail@example.com|
|Contact: Cesare Greco, MD||+39 335 firstname.lastname@example.org|
|University La Sapienza||Not yet recruiting|
|Rome, Italy, 00166|
|Principal Investigator: Francesco Pelliccia, MD, PhD|