Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis

NCT04366596 | Unknown Phase 3 DMC

• 1 other identifier: HS-2133
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy of drug eluting balloon(DEB) for non-atherosclerotic renal artery stenosis will be tested in this study. The intervention group will be treated with paclitaxel eluting balloon. The control group will be treated with plain old balloon(POB). The primary endpoint is efficacy of blood pressure control.

Conditions

Hypertension, Renovascular

Keywords

Renal Artery Obstruction; Takayasu Arteritis; Fibromuscular Dysplasia

Outcome Measures

Primary Outcomes (2)

• Clinical benefit rate(cure or improvement of hypertension)

  Cure: diastolic blood pressure \<90 mm Hg and systolic blood pressure \<140 mm Hg off antihypertensive medications. Improvement: diastolic blood pressure \<90 mm Hg and/or systolic blood pressure \<140 mm Hg on the same or reduced number of medications (or reduced number of defined daily doses as described by the World Health Organization ) or a reduction in diastolic blood pressure by at least 15 mm Hg on the same or reduced number of medications

  9 months

• Primary patency rate

  uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass

  9 months

Secondary Outcomes (9)

• Technical success rate

  immediately after intervention

• complication rate

  within 30 days post-intervention

• Bail-out stenting rate

  during the procedure

• Clinical benefit rate

  1, 3,6,12 months

• primary patency rate

  6,12 months

Study Arms (2)

DEB group

EXPERIMENTAL

angioplasty with paclitaxel eluting balloon

Device: Angioplasty with paclitaxel eluting balloon

POB group

PLACEBO COMPARATOR

Angioplasty with plain old balloon

Device: Angioplasty with plain old balloon

Interventions

Angioplasty with paclitaxel eluting balloon DEVICE

The patients will be treated with renal artery angioplasty using paclitaxel eluting balloon

DEB group

Angioplasty with plain old balloon DEVICE

Angioplasty with plain old balloon

POB group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age between 18y and 45y.
• with ≥ 60% stenosis in at least one renal artery.
• with hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg).
• patients with no severe renal insufficiency (eGFR\>30 ml/min, length of the kidney ≥ 7cm).
• Good compliance.
• with informed consent.

You may not qualify if:

• With apparent atherosclerotic risk factors.
• With renal intervention or surgery history.
• With congenital anatomical anomaly.
• With severe renal insufficiency (length of the target kidney \< 7cm, total eGFR\<30ml/min, divided eGFR of the target kidney\<8 ml/min)
• With contraindication for antiplatelet therapy.
• With severe cardiopulmonary insufficiency.
• Allergic to contrast medium
• Being pregnant or preparing for pregnancy
• With active cancer.
• Life expectancy \< 12 month
• Without informed consent.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Hypertension, Renovascular; Renal Artery Obstruction; Takayasu Arteritis; Fibromuscular Dysplasia

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Hypertension, Renal; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Aortic Arch Syndromes; Aortic Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Yuehong Zheng, MD

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Xitao Song, MD

CONTACT

96-10-69152501; sxitao@sina.com

Yuexin Chen, MD

CONTACT

96-10-69152502; cyuexin2007@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients are randomly allocated into intervention and control group. The investigator and outcomes assessor only kwow the random number. The participants will not be told the exact group that they were allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: intervention group: treated with drug eluting balloon control group :treated with plain old balloon

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: April 29, 2020
• Study Start: October 1, 2019
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 29, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)