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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRS group | Experimental |
| |
| DCB group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| percentage diameter stenosis | 12 months |
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Inclusion Criteria:
- Radiography inclusion criteria
Exclusion Criteria:
1. in-stent lesions; 2. For the left main disease, chronic total occlusive lesions; 3. bifurcation lesion (reference vessel diameter of side branch vessels > 2.0 mm); 4. Severely calcified lesions and tortuous lesions; lesions that have failed pretreatment; lesions unsuitable for balloon delivery and dilatation; 5. Previous use of any brand of drug-coated balloon in the target vessel. General inclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yaojun zhang, Ph.D. | Contact | 0516-85786383 | mts0207@163.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32138967 | Background | 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. | |
| 31204115 | 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. |
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| 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. |
|
| 34154628 | Result | Hao X, Huang D, Wang Z, Zhang J, Liu H, Lu Y. Study on the safety and effectiveness of drug-coated balloons in patients with acute myocardial infarction. J Cardiothorac Surg. 2021 Jun 21;16(1):178. doi: 10.1186/s13019-021-01525-8. |
| 38333846 | Result | Jiang JL, Huang QJ, Chen MH. Efficacy and safety of drug-coated balloon for de novo lesions of large coronary arteries: Systematic review and meta-analysis of randomized controlled trials. Heliyon. 2024 Jan 30;10(3):e25264. doi: 10.1016/j.heliyon.2024.e25264. eCollection 2024 Feb 15. |
| 33842993 | Result | 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. |
| 34759131 | Result | 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. |
| 35112669 | Result | 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. |
| 31009399 | Result | 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. |
| 27494722 | Result | 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. |
| 29208251 | Result | 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. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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