BridgeMD
Tests treatment safety and results for Essential Hypertension
Official title To Evaluate the Safety and Efficacy of a Single-Use IVUS Ablation for Primary Hypertension
ClinicalTrials.gov ID: NCT07051811
What this study is testing
- What it's testing
- This is a prospective, multicenter, blinded, randomized controlled clinical trial designed to evaluate the safety and efficacy of a single-use intravascular ultrasound ablation catheter and ultrasound ablation system in the treatment of primary hypertension.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Aged ≥18 years and ≤75 years, regardless of gender.
- Documented history of primary hypertension.
- Stable use of at least two antihypertensive medications for a minimum of 4 consecutive weeks prior to randomization, specifically requiring a...
- Office systolic blood pressure (SBP) ≥150 mmHg and \<180 mmHg;
- Office diastolic blood pressure (DBP) ≥90 mmHg;
You likely can't join if
- Unsuitable Renal Artery Anatomy for Treatment
- Main renal artery diameter \<4 mm or length \<20 mm.
- Accessory renal artery diameter ≥ 2 mm and \<4 mm.
- Renal artery stenosis \>50% in the main renal artery.
- Renal artery aneurysm, fibromuscular dysplasia, or severe calcification.
- Presence of a renal artery stent.
See the full eligibility criteria
- Aged ≥18 years and ≤75 years, regardless of gender.
- Documented history of primary hypertension.
- Stable use of at least two antihypertensive medications for a minimum of 4 consecutive weeks prior to randomization, specifically requiring a combination of an angiotensin II receptor blocker (ARB) and a calcium channel...
- Office systolic blood pressure (SBP) ≥150 mmHg and \<180 mmHg;
- Office diastolic blood pressure (DBP) ≥90 mmHg;
- 24-hour ambulatory systolic blood pressure ≥135 mmHg and \<170 mmHg.
- Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to comply with clinical follow-up.
- Unsuitable Renal Artery Anatomy for Treatment
- Main renal artery diameter \<4 mm or length \<20 mm.
- Accessory renal artery diameter ≥ 2 mm and \<4 mm.
- Renal artery stenosis \>50% in the main renal artery.
- Renal artery aneurysm, fibromuscular dysplasia, or severe calcification.
- Presence of a renal artery stent.
- Single kidney.
- Estimated Glomerular Filtration Rate (eGFR) \<45 mL/min/1.73 m².
- Diagnosis of Type 1 Diabetes Mellitus.
- Orthostatic Hypotension.
- Recent Vascular Events:Acute myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months prior to signing the informed consent form.
- Suspected Secondary Hypertension.
- Respiratory Support:a) Requirement for long-term oxygen support or mechanical ventilation (excluding nocturnal respiratory support for sleep apnea).
- Prior Renal Artery Denervation Procedure.
- Life Expectancy \<1 Year.
- Pregnancy, Lactation, or Plans to Become Pregnant Within 6 Months (for Females); Males Planning to Conceive Within 6 Months.
- Current Participation in Another Clinical Trial Without Completion of the Primary Endpoint.
- Allergy to Contrast Agents.
- Other Reasons Deemed by the Investigator to Make the Subject Unsuitable for Participation (e.g., Poor Compliance).
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Xiamen, Fujian, China
- Lanzhou, Gansu, China
- Shenzhen, Guangdong, China
- Zhengzhou, Henan, China
- Hohhot, Neimenggu, China
- Yinchuan, Ningxia, China
- Xining, Qinghai, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Xi’an, Shanxi, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Xiamen, Fujian, China; Lanzhou, Gansu, China; Shenzhen, Guangdong, China; Zhengzhou, Henan, China and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.