Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447740
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-02
Brief Title:
Fractional Flow Reserve-guided Stenting Versus Medical Therapy in Atherosclerosis Renal Artery Stenosis
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
Fractional Flow Reserve-guided Percutaneous Renal Artery Stenting Plus Optimal Medical Therapy Versus Optimal Medical Therapy Alone In Atherosclerosis Renal-vascular Hypertension Patients a Multicenter Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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:
FAIR
Brief Summary:
Although randomized trials have demonstrated there is no benefit of renal-artery stenting in addition to medical therapy for patients with atherosclerosis renal artery stenosis many patients indeed gained benefit in daily practices after stenting such as reduction in blood pressure and recovery in renal functions One important gap is that there is no universal standard to determine whether to stent in these patients Fraction Flow Reserve FFR has been studied for many year in chronic coronary heart disease and FFR-guided revascularization strategy is known to be better than both angiography-guided revascularization and medication alone Based on the primary finding of FAIR-pilot study NCT05732077 FFR-guided renal artery stenting is practical
The overall purpose of the FAIR trial is to compare the clinical outcomes and safety of FFR-guided stenting plus optimal medical treatment OMT versus OMT alone in patients with renal-vascular hypertensive patients
With the all comers design participants met the inclusiveexclusive criteria will be enrolled and hyperemic FFR induced by dopamine will be measured in all participants If FFR is 080 patients will be treated with OMT alone and follow up If FFR is 080 participants will be randomized to stenting in the renal artery plus OMT or OMT alone on a 11 ratio The blood pressure and anti-hypertensive medications will be compared before and 3 months after the procedure based on ambulatory blood pressure monitoring all participants will be followed up for 1 year
The overall purpose of the FAIR trial is to compare the clinical outcomes and safety of FFR-guided stenting plus optimal medical treatment OMT versus OMT alone in patients with renal-vascular hypertensive patients
With the all comers design participants met the inclusiveexclusive criteria will be enrolled and hyperemic FFR induced by dopamine will be measured in all participants If FFR is 080 patients will be treated with OMT alone and follow up If FFR is 080 participants will be randomized to stenting in the renal artery plus OMT or OMT alone on a 11 ratio The blood pressure and anti-hypertensive medications will be compared before and 3 months after the procedure based on ambulatory blood pressure monitoring all participants will be followed up for 1 year
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None