COMPARE-II- Vasomotion and Imaging Substudy

NCT01329237 | Unknown Phase 4

• 1 other identifier: COMPARE-II-Imaging
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare strut coverage and neointimal thickness between everolimus eluting (XIENCE-V® or PROMUS® stent) and biolimus A9 eluting NOBORI Stent 14 months after stent implantation and to determine the coronary endothelial function after everolimus eluting (XIENCE-V® or PROMUS® stent) and biolimus A9 eluting NOBORI Stent 14 months after stent implantation by using supine bicycle exercise testing to assess coronary vasomotor response to exercise.

Conditions

Coronary Artery Disease

Keywords

drug-eluting stent; coronary endothelial function; coronary imaging

Outcome Measures

Primary Outcomes (1)

• percentage of uncovered stent struts per lesion assessed by OCT

  within 14 months after percutaneous coronary stent implantation

Secondary Outcomes (2)

• coronary vasomotor function

  within 14 months after stentimplantation

• mean neointimal thickness assessed by OCT

  within 14 months after stent implantation

Study Arms (1)

dynamic physical exercise OCT

OTHER

dynamic physical exercise and optical coherence tomography imaging

Other: dynamic physical exercise and OCT imaging

Interventions

dynamic physical exercise and OCT imaging OTHER

supine dynamic physical exercise during coronary angiography and optical coherence tomography OCT imaging of the coronary stent

dynamic physical exercise OCT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient enrolled in the COMPARE II trial with successful stent implantation and absence of binary restenosis or severe progression of coronary artery disease at 14 months follow-up.
• Patient consent to undergo a non-scheduled follow- up angiography with imaging study and bicycle exercise testing

You may not qualify if:

• Inability to provide informed consent
• Inability to perform a supine bicycle exercise stress test
• Binary in stent restenosis of the target vessel
• Acute Coronary Syndrome, Acute Myocardial Infarction
• Patients with stent thrombosis following the index procedure
• Female of childbearing potential ( age ≤ 50 years and last menstruation within the last 12 months ), who did not undergo tubal ligation, ovariectomy or hysterectomy
• Known intolerance to heparin, contrast material
• History of bleeding diathesis or known coagulopathy
• Age ≥ 80 years
• Hemodynamic instability
• Renal failure (creatinine clearance ≤ 40 ml/min)
• OCT / IVUS technically not feasible

Sponsors & Collaborators

• University of Freiburg: lead

Study Sites (1)

Hopital Cantonal HFR

Fribourg, Canton of Fribourg, 1708, Switzerland

RECRUITING

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

• Mario Togni, MD

  University of Fribourg, Switzerland

  PRINCIPAL INVESTIGATOR

• Stéphane Cook, MD

  University of Fribourg, Switzerland

  PRINCIPAL INVESTIGATOR

• Jean-Christophe Stauffer, MD

  Hopital Cantonal HFR, Fribourg, Switzerland

  STUDY CHAIR

• Jean-Jacques Goy, MD

  Hopital Cantonal HFR, Fribourg, Switzerland

  STUDY CHAIR

• Gérard Baeriswyl, MD

  Hopital Cantonal HFR, Fribourg, Switzerland

  STUDY CHAIR

• Pieter C Smits, MD, PhD

  Maasstad Ziekenhuis, Rotterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Togni, MD

CONTACT

++41-26-426-8130; mario.togni@unifr.ch

Stéphane Cook, MD

CONTACT

++41-26-426-8130; stephane.cook@unifr.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: April 5, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Last Updated: April 5, 2011

Record last verified: 2011-01

Locations

CH (1)