Fractional Flow Reserve to Determine Atherosclerosis Renovascular Hypertension Stenting

Last updated: June 4, 2024
Sponsor: Peking University First Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Vascular Diseases

Williams Syndrome

Treatment

Renal artery stenting

Dopamine

Fractional Flow Reserve, Renal

Clinical Study ID

NCT05732077
2022CR77
  • Ages > 18
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • With recorded hypertension, AND the blood pressure is not controlled (SBP ≥140mmHgand/or DBP ≥90mmHg) on 2 or more classes of anti-hypertensive 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 1 main artery with stenosis of 50%-90%, ANDthe diameter is ≥ 4.0mm.

Exclusion

Exclusion Criteria:

  • SBP ≥200mmHg and/or DBP ≥120mmHg at the day or randomization;

  • Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis;

  • Pregnancy or unknow pregnancy status in female of childbearing potential;

  • Participation in any drug or device trial during the study period;

  • Any stroke/TIA, OR with ≥70% stenosis of carotid artery;

  • Any major surgery, myocardial infarction or interventional therapy 30 days prior tostudy entry;

  • LVEF <30%;

  • Comorbid condition causing life expectancy ≤1 year;

  • Allergy to contrast or any of the following: aspirin, clopidogrel;

  • Previous kidney transplant;

  • Previous renal artery bypass surgery or stent intervention;

  • Kidney size less than 8 cm measured by ultrasound;

  • Local lab serum Cr >3.0 mg/dl (265.2μmol/l) on the day of randomization;

  • Reference vessel size <4 mm or >8 mm.

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Renal artery stenting
Phase:
Study Start date:
January 31, 2023
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing
    China

    Active - Recruiting

  • Beijing Chao-yang hospital, capital medical university

    Beijing, Beijing 100123
    China

    Active - Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing
    China

    Active - Recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing 100029
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Active - Recruiting

  • Qinghai province cardiovascular and cerebrovascular disease specialist hospital

    Xining, Qinghai 810012
    China

    Active - Recruiting

  • Zibo Central Hospital

    Zibo, Shandong
    China

    Active - Recruiting

  • Peking University First Hospital Taiyuan Hospital

    Taiyuan, Shanxi 030009
    China

    Active - Recruiting

  • Tianjin Beichen Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

  • Tianjin First Central Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.