Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05732077

Fractional Flow Reserve to Determine Atherosclerosis Renovascular Hypertension Stenting

Led by Peking University First Hospital · Updated on 2024-06-06

100

Participants Needed

13

Research Sites

112 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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. The goal of this clinical trial is to learn whether Fraction Flow Reserve (FFR) is appropriate to determine stenting in hypertension patients with atherosclerosis renal artery stenosis. The main questions it aims to answer are: * Is it appropriate to use FFR to determine whether or not stenting for hypertension patients with atherosclerosis renal artery stenosis? * To provide detailed data supporting design of further trial, such as sample size calculating, cut-off value for FFR in renal artery stenosis, etc. Participants met the inclusive/exclusive criteria will be randomized to stenting or not in the renal artery, then hyperemic FFR induced by dopamine will be measured in all participants. If FFR is ≥0.80, randomization will be applied. If FFR is \<0.80, randomization will be ignored, and stenting will be performed as planned. 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.

CONDITIONS

Official Title

Fractional Flow Reserve to Determine Atherosclerosis Renovascular Hypertension Stenting

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have recorded hypertension with blood pressure not controlled (SBP ≥140 mmHg and/or DBP ≥90 mmHg) despite using two or more classes of antihypertensive drugs
  • Evidence of renal artery stenosis and undergoing renal artery angiography
  • Able to follow the study protocol and provide informed consent
  • Renal artery angiography shows at least one main artery with 50% to 90% stenosis and diameter of at least 4.0 mm
Not Eligible

You will not qualify if you...

  • Systolic blood pressure ≥200 mmHg and/or diastolic blood pressure ≥120 mmHg at the day of randomization
  • Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis
  • Pregnancy or unknown pregnancy status in females of childbearing potential
  • Participation in any drug or device trial during the study period
  • Any stroke or transient ischemic attack (TIA), or ≥70% stenosis of carotid artery
  • Major surgery, heart attack, or interventional therapy within 30 days before study entry
  • Left ventricular ejection fraction (LVEF) less than 30%
  • Comorbid condition with life expectancy of one year or less
  • Allergy to contrast agents, aspirin, or clopidogrel
  • Previous kidney transplant
  • Previous renal artery bypass surgery or stent intervention
  • Kidney size less than 8 cm measured by ultrasound
  • Local lab serum creatinine greater than 3.0 mg/dl on day of randomization
  • Reference vessel size less than 4 mm or greater than 8 mm

AI-Screening

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Trial Site Locations

Total: 13 locations

1

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China, 100029

Actively Recruiting

2

Peking University First Hospital

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

3

Beijing Chao-yang hospital, capital medical university

Beijing, Beijing Municipality, China, 100123

Actively Recruiting

4

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Actively Recruiting

5

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Actively Recruiting

6

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Actively Recruiting

7

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Actively Recruiting

8

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Actively Recruiting

9

Qinghai province cardiovascular and cerebrovascular disease specialist hospital

Xining, Qinghai, China, 810012

Actively Recruiting

10

Zibo Central Hospital

Zibo, Shandong, China

Actively Recruiting

11

Peking University First Hospital Taiyuan Hospital

Taiyuan, Shanxi, China, 030009

Actively Recruiting

12

Tianjin Beichen Hospital

Tianjin, Tianjin Municipality, China

Actively Recruiting

13

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

Actively Recruiting

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Research Team

Y

Yuxi Li, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Fractional Flow Reserve to Determine Atherosclerosis Renovascular Hypertension Stenting | DecenTrialz