COMPARE-II- Vasomotion and Imaging Substudy

Coronary Artery Disease Clinical Trial

— COMPARE-IT  

Official title:

Comparison of the Everolimus Eluting (XIENCE-V® or PROMUS® Stent) With the Biolimus A9 Eluting NOBORI® Stent in All-comers: a Randomized Open Label Study The COMPARE II Trial Imaging and Vasomotion Substudy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01329237
• Other study ID #: COMPARE-II-Imaging
• Status: Recruiting
• Phase: Phase 4
• First received: March 28, 2011
• Last updated: April 4, 2011
• Start date: March 2011

Study information

• Verified date: January 2011
• Source: University of Freiburg
• Contact: Mario Togni, MD
• Phone: ++41-26-426-8130
• Email: mario.togni[@]unifr.ch
• Is FDA regulated: No
• Health authority: Switzerland: Comission d'éthique et de recherche état de Fribourg
• Study type: Interventional

Clinical Trial 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.

Description:

DESIGN:

Imaging and vasomotion Substudy:

50 consecutive patients enrolled in the COMPARE II trial at the University of Fribourg Medical Center will undergo follow-up re-angiography 14 months after index procedure with assessment of Optical coherence tomography (OCT) and vasomotion testing.

ENDPOINT SUBSTUDY (all at 14 months):

Primary endpoint imaging: percentage of uncovered stent struts per lesion and mean neointimal thickness assessed by OCT.

vasomotion: coronary vasomotion assessed with quantitative coronary angiography at rest and during supine bicycle exercise.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

1. Inability to provide informed consent

2. Inability to perform a supine bicycle exercise stress test

3. Binary in stent restenosis of the target vessel

4. Acute Coronary Syndrome, Acute Myocardial Infarction

5. Patients with stent thrombosis following the index procedure

6. Female of childbearing potential ( age = 50 years and last menstruation within the last 12 months ), who did not undergo tubal ligation, ovariectomy or hysterectomy

7. Known intolerance to heparin, contrast material

8. History of bleeding diathesis or known coagulopathy

9. Age = 80 years

10. Hemodynamic instability

11. Renal failure (creatinine clearance = 40 ml/min)

12. OCT / IVUS technically not feasible

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Switzerland	Hopital Cantonal HFR	Fribourg

Sponsors (1)

Lead Sponsor	Collaborator
University of Freiburg

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of uncovered stent struts per lesion assessed by OCT		within 14 months after percutaneous coronary stent implantation	Yes
Secondary	coronary vasomotor function	coronary vasomotion assessed with quantitative coronary angiography at rest and during supine bicycle exercise	within 14 months after stentimplantation	Yes
Secondary	mean neointimal thickness assessed by OCT		within 14 months after stent implantation	Yes