NCT01489202

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 9, 2011

Completed
2.7 years until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

1.2 years

First QC Date

December 6, 2011

Last Update Submit

March 6, 2013

Conditions

Coronary Artery Disease

Keywords

drug-eluting stentpercutaneous coronary intervention

Outcome Measures

Primary Outcomes (2)

  • Post-PCI changes in markers of endothelial damage

    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)

    Baseline and 24 hours after PCI

  • Post-PCI changes in markers of inflammation

    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)

    Baseline and 24 hours after PCI

Secondary Outcomes (1)

  • 12-month rate of MACE

    Up to 12 months

Study Arms (2)

platinum chromium EES

ACTIVE COMPARATOR

Patients undergoing PCI with stenting will have implantation of platinum chromium everolimus-eluting stents

Device: platinum chromium everolimus-eluting stent

cobalt chromium everolimus-eluting stent

ACTIVE COMPARATOR

Patients undergoing PCI with stenting will have implantation of cobalt chromium everolimus-eluting stents

Device: cobalt chromium everolimus-eluting stent

Interventions

platinum chromium everolimus-eluting stentDEVICE

An everolimus-eluting stent with a platinum chromium platform

Also known as: Promus ElementTM, Boston Scientific Corporation, Natick, MA, USA
platinum chromium EES
cobalt chromium everolimus-eluting stentDEVICE

An everolimus-eluting stent with cobalt chromium platform

Also known as: Xience VTM, Abbott Laboratories, Abbott Park, IL, USA
cobalt chromium everolimus-eluting stent

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University La Sapienza

Rome, 00166, Italy

Location

Related Publications (1)

  • 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. No abstract available.

    PMID: 22360944DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Francesco Pelliccia, MD, PhD

CONTACT

+393483392006f.pelliccia@mclink.it

Cesare Greco, MD

CONTACT

+39 335 8381320cesare.greco@uniroma1.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 6, 2011

First Posted

December 9, 2011

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations

IT(1)