The Safety and Efficacy of New-Generation BRS vs. DCB for De Novo Large Coronary Artery Lesions: A Prospective RCT

NCT07162792 | Not Yet Recruiting

• 1 other identifier: 2025-02-011-H01
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study plans to enroll 150 patients who are candidates for "intervention without implantation" therapy and they will be randomly assigned in a 1:1 ratio to either the new-generation Firesorb scaffold group (BRS group, N=75) or the drug-coated balloon group (DCB group, N=75). All enrolled patients will undergo angiographic follow-up at 1 year post-procedure, and serial follow-up (via telephone or outpatient visit) will be performed at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-procedure. The primary study endpoint was percentage diameter stenosis at 1 year post-procedure.

Conditions

Coronary Artery Disease(CAD); de Novo Coronary Lesions

Keywords

drug-coated balloon; percutaneous coronary intervention; bioresorbable scaffold

Outcome Measures

Primary Outcomes (1)

• percentage diameter stenosis

  12 months

Study Arms (2)

BRS group

EXPERIMENTAL

Device: bioresorbable scaffold

DCB group

EXPERIMENTAL

Device: drug-coated balloon

Interventions

bioresorbable scaffold DEVICE

75 subjects with de novo large vessel coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of BRS.

BRS group

drug-coated balloon DEVICE

75 subjects with de novo large vessel coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of DCB.

DCB group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• angiographically confirmed de novo coronary artery lesion;
• target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);
• target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤25mm (visual assessment);
• either one or two target lesions to be treated; if two target lesions, they must be located in different target vessels;
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• subjects at the age between ≥18 and ≤80 years old;
• patients with symptoms or evidence of myocardial ischaemia;
• subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up after operation.

You may not qualify if:

• Any patient with myocardial infarction within one month;
• Patients with severe congestive heart failure (NYHA Level III severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 40%;
• Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;
• Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;
• Patients with severe renal failure(eGFR\<30ml/minute) or such medical history, failure to comply with angiography conditions;
• Subjects who are intolerance or allergic to heparin, contrast agent, polyethylene oxide and polylactic acid - glycolic acid polymer;
• Patients who plans to accept selective operation within 1 year;
• Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
• Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.

Sponsors & Collaborators

• Xuzhou Third People's Hospital: lead

Related Publications (10)

• Yerasi C, Case BC, Forrestal BJ, Torguson R, Weintraub WS, Garcia-Garcia HM, Waksman R. Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Mar 10;75(9):1061-1073. doi: 10.1016/j.jacc.2019.12.046.

  PMID: 32138967 BACKGROUND

• Salloum E, Ohri A, Bartlett F, Ivey T, Savona S. Priapism in sickle cell disease: possible contributory effect of cocaine use. Arch Intern Med. 1993 Oct 11;153(19):2287. No abstract available.

  PMID: 8215732 BACKGROUND

• Gauthier BM, Hickner JM, Ornstein S. High prevalence of overweight children and adolescents in the Practice Partner Research Network. Arch Pediatr Adolesc Med. 2000 Jun;154(6):625-8. doi: 10.1001/archpedi.154.6.625.

  PMID: 10850513 BACKGROUND

• Yu X, Wang X, Ji F, Zhang W, Yang C, Xu F, Wang F. Correction to: A Non-inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions. Cardiovasc Drugs Ther. 2022 Dec;36(6):1261-1262. doi: 10.1007/s10557-021-07183-1. No abstract available.

  PMID: 33842993 BACKGROUND

• Wang Z, Yin Y, Li J, Qi W, Yu B, Xu Z, Zhu W, Yang F, Cao M, Zhang H. New Ultrasound-Controlled Paclitaxel Releasing Balloon vs. Asymmetric Drug-Eluting Stent in Primary ST-Segment Elevation Myocardial Infarction - A Prospective Randomized Trial. Circ J. 2022 Mar 25;86(4):642-650. doi: 10.1253/circj.CJ-21-0315. Epub 2021 Nov 10.

  PMID: 34759131 BACKGROUND

• Vos NS, Amoroso G, Herrman JR, Patterson MS, van der Schaaf RJ, Slagboom T, Vink MA. Pronounced late acquired focal coronary artery dilatation after paclitaxel-coated balloon angioplasty: observations from the randomized REVascularization With PaclitaxEL-Coated Balloon Angioplasty Versus Drug-Eluting Stenting in Acute Myocardial InfarcTION (REVELATION) trial. Coron Artery Dis. 2022 Mar 1;33(2):151-152. doi: 10.1097/MCA.0000000000001047. No abstract available.

  PMID: 35112669 BACKGROUND

• Shin ES, Lee JM, Her AY, Chung JH, Eun Lee K, Garg S, Nam CW, Doh JH, Koo BK. Prospective randomized trial of paclitaxel-coated balloon versus bare-metal stent in high bleeding risk patients with de novo coronary artery lesions. Coron Artery Dis. 2019 Sep;30(6):425-431. doi: 10.1097/MCA.0000000000000755.

  PMID: 31009399 BACKGROUND

• Rissanen TT, Uskela S, Eranen J, Mantyla P, Olli A, Romppanen H, Siljander A, Pietila M, Minkkinen MJ, Tervo J, Karkkainen JM; DEBUT trial investigators. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet. 2019 Jul 20;394(10194):230-239. doi: 10.1016/S0140-6736(19)31126-2. Epub 2019 Jun 13.

  PMID: 31204115 BACKGROUND

• Nishiyama N, Komatsu T, Kuroyanagi T, Fujikake A, Komatsu S, Nakamura H, Yamada K, Nakahara S, Kobayashi S, Taguchi I. Clinical value of drug-coated balloon angioplasty for de novo lesions in patients with coronary artery disease. Int J Cardiol. 2016 Nov 1;222:113-118. doi: 10.1016/j.ijcard.2016.07.156. Epub 2016 Jul 27.

  PMID: 27494722 BACKGROUND

• Gobic D, Tomulic V, Lulic D, Zidan D, Brusich S, Jakljevic T, Zaputovic L. Drug-Coated Balloon Versus Drug-Eluting Stent in Primary Percutaneous Coronary Intervention: A Feasibility Study. Am J Med Sci. 2017 Dec;354(6):553-560. doi: 10.1016/j.amjms.2017.07.005. Epub 2017 Jul 19.

  PMID: 29208251 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

yaojun zhang, Ph.D.

CONTACT

0516-85786383; mts0207@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: October 23, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share