Effects of a rapamycIn-eluting carboNized Stent With a Completely biodEgradable polymeR Coating

NCT01981304 | Unknown

• 1 other identifier: 807/2013/D
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Percutaneous coronary intervention with stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to the occurrence of major adverse cardiac events (MACE), such as restenosis, atherosclerosis, and stent thrombosis. Drugs, platforms and polymers are considered the protagonists of these pathophysiologic processes. The objectives of the INERT study is to assess the extent of inflammation and endothelial damage induced by the first carbonized bio-absorbable coated rapamycin-eluting coronary stent at time of percutaneous coronary intervention and correlate the extent of these abnormalities with short and long-term clinical outcome and post-procedural evaluation of success. As part of the study, a randomized sub-study will be carried out at the Coordinating Center in order to compare the biohumoral, clinical and procedural findings between patients with the carbonized bio-absorbable coated rapamycin-eluting coronary stent and those randomly assigned to receive stents with different platforms and polymers.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Post-PCI changes in markers of inflammation and endothelial damage

  Changes 4 months after PCI in indexes of endothelial damage (von Willebrand Factor, sE-selectin, Vascular cell adhesion molecule, Intercellular adhesion molecule) and inflammation (C-reactive protein, Fibrinogen, Plasminogen activator inhibitor, Interleukin-6)

  Baseline and 4 months after PCI

Secondary Outcomes (1)

• 12-month rate of MACE

  Up to 12 months

Study Arms (1)

DES with a biodegradable polymer coating

Patients receiving the first carbonized bio-absorbable coated rapamycin-eluting coronary stent at time of percutaneous coronary intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Coronary artery disease

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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Cesare Greco, MD

  University Sapienza

  STUDY CHAIR

Central Study Contacts

FRANCESCO PELLICCIA

CONTACT

f.pelliccia@mclink.it

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 11, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: November 13, 2013

Record last verified: 2013-11