Ignite Creation Date:
2024-05-06 @ 1:41 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01876589
Status:
UNKNOWN
Last Update Posted:
2016-08-02
First Post:
2013-06-10
Brief Title:
Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusiona Randomized H215O PETCT Study
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion a Randomized H215O PETCT Study
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VANISH
Brief Summary:
The purpose of this study is to examine the improvement of myocardial blood flow induced by regained vasomotor functions of the stented coronary segment after resorption of BVS over time
Detailed Description:
Objective The objective of the proposed study is to determine the impact of VRT in comparison with conventional drug-eluting stenting on endothelium dependent vasodilation and maximal hyperemic myocardial perfusion using H215O PET
Study design The study is designed as a single center single-blind randomized clinical trial and will be conducted at the VU University Medical Center in Amsterdam
Summary of the study design It is hypothesized that VRT will result in augmented endothelium dependent coronary vasodilation and maximal myocardial perfusion as compared with conventional stenting of a coronary lesion Within one year sixty patients age 18-65 with documented single vessel CAD type A or B1 lesion accepted for PCI based on clinical grounds and according to current international guidelines will be asked to participate in this trial Patients will be randomized to implantation of a drug-eluted stent Xience Prime or BRS Absorb The patients will be blinded to the nature of the implanted device H2 15O PET will be performed one month reference scan one year and three years after the PCI procedure resolution of BRS is generally complete within a three year period The PET protocol will consist of three MBF measurements resting MBF during endothelial dependent vasodilation provoked by coldpressor-testing CPT and during endothelial dependent and independent maximal vasodilation by infusion of adenosine intravenously After three years a control invasive coronary angiogram will document any potential obstructive coronary lesions that may affect the MBF measurements
Primary study parametersoutcome of the study MBF measurements resting MBF during endothelial dependent vasodilation provoked by cold-pressor-testing CPT and during endothelial dependent and independent maximal vasodilation by infusion of adenosine intravenously
Secondary study parametersoutcome of the study Obstructive coronary lesions on control invasive coronary angiogram that may affect the MBF measurements
Study design The study is designed as a single center single-blind randomized clinical trial and will be conducted at the VU University Medical Center in Amsterdam
Summary of the study design It is hypothesized that VRT will result in augmented endothelium dependent coronary vasodilation and maximal myocardial perfusion as compared with conventional stenting of a coronary lesion Within one year sixty patients age 18-65 with documented single vessel CAD type A or B1 lesion accepted for PCI based on clinical grounds and according to current international guidelines will be asked to participate in this trial Patients will be randomized to implantation of a drug-eluted stent Xience Prime or BRS Absorb The patients will be blinded to the nature of the implanted device H2 15O PET will be performed one month reference scan one year and three years after the PCI procedure resolution of BRS is generally complete within a three year period The PET protocol will consist of three MBF measurements resting MBF during endothelial dependent vasodilation provoked by coldpressor-testing CPT and during endothelial dependent and independent maximal vasodilation by infusion of adenosine intravenously After three years a control invasive coronary angiogram will document any potential obstructive coronary lesions that may affect the MBF measurements
Primary study parametersoutcome of the study MBF measurements resting MBF during endothelial dependent vasodilation provoked by cold-pressor-testing CPT and during endothelial dependent and independent maximal vasodilation by infusion of adenosine intravenously
Secondary study parametersoutcome of the study Obstructive coronary lesions on control invasive coronary angiogram that may affect the MBF measurements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None