Effects of DES Platforms on Markers of Endothelial Damage and Inflammation (PLATFORM)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01489202
First received: December 6, 2011
Last updated: March 6, 2013
Last verified: March 2013

December 6, 2011
March 6, 2013
September 2014
December 2015   (final data collection date for primary outcome measure)
  • Post-PCI changes in markers of endothelial damage [ Time Frame: Baseline and 24 hours after PCI ] [ Designated as safety issue: No ]

    Changes 24 hours after PCI in the following indexes of endothelial damage:

    1. von Willebrand Factor (vWF)
    2. sE-selectin
    3. Vascular cell adhesion molecule (sVCAM-1)
    4. Intercellular adhesion molecule (sICAM-1)
  • Post-PCI changes in markers of inflammation [ Time Frame: Baseline and 24 hours after PCI ] [ Designated as safety issue: No ]

    Changes 24 hours after PCI in the following inflammatory markers:

    1. C-reactive protein (CPR)
    2. Fibrinogen
    3. Plasminogen activator inhibitor (PAI-1)
    4. Interleukin-6 (IL-6)
Same as current
Complete list of historical versions of study NCT01489202 on ClinicalTrials.gov Archive Site
12-month rate of MACE [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
12-months incidence of major adverse cardiac events (MACE—death, myocardial infarction, target vessel revascularization)
Same as current
Not Provided
Not Provided
 
Effects of DES Platforms on Markers of Endothelial Damage and Inflammation
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

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.It remains unknown, conversely, if stent platforms affect the extent of post-PCI endothelial damage and inflammation.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Coronary Artery Disease
  • 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
  • Device: cobalt chromium everolimus-eluting stent
    An everolimus-eluting stent with cobalt chromium platform
    Other Name: Xience VTM, Abbott Laboratories, Abbott Park, IL, USA
  • Active Comparator: platinum chromium EES
    Patients undergoing PCI with stenting will have implantation of platinum chromium everolimus-eluting stents
    Intervention: Device: platinum chromium everolimus-eluting stent
  • Active Comparator: cobalt chromium everolimus-eluting stent
    Patients undergoing PCI with stenting will have implantation of cobalt chromium everolimus-eluting stents
    Intervention: Device: cobalt chromium everolimus-eluting stent
Pelliccia F, Del Prete G, Del Prete A, Greco C, Gaudio C. Effects of percutaneous coronary intervention and stenting with different drug-eluting coatings and platforms on endothelial damage and inflammation. Int J Cardiol. 2012 Apr 19;156(2):242-3. doi: 10.1016/j.ijcard.2012.01.059. Epub 2012 Feb 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
December 2016
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A de novo native coronary artery lesions (reference vessel diameter:2.5-3.75 mm)
  • Class I indication to elective percutaneous coronary intervention
  • Stable conditions and no recent acute coronary syndromes
  • Normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-MB, myoglobin, and troponin I)
  • Able to understand and willing to sign the informed CF

Exclusion Criteria:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

Both
Not Provided
No
Contact: Francesco Pelliccia, MD, PhD +393483392006 f.pelliccia@mclink.it
Contact: Cesare Greco, MD +39 335 8381320 cesare.greco@uniroma1.it
Italy
 
NCT01489202
655/2011/D
No
Francesco Pelliccia, University of Roma La Sapienza
University of Roma La Sapienza
Not Provided
Not Provided
University of Roma La Sapienza
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP