Coronary Artery Disease(CAD), de Novo Coronary Lesions
Conditions
Keywords
drug-coated balloon, percutaneous coronary intervention, bioresorbable scaffold
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.
Interventions
DEVICEbioresorbable scaffold
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.
DEVICEdrug-coated balloon
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.
Sponsors
Xuzhou Third People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* \- Radiography inclusion criteria 1. angiographically confirmed de novo coronary artery lesion; 2. target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment); 3. target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤25mm (visual assessment); 4. either one or two target lesions to be treated; if two target lesions, they must be located in different target vessels; 5. successful target lesion preparation: residual stenosis ≤30%, no flow-restricting entrapment, and TIMI grade 3 flow; General inclusion criteria <!-- --> 1. subjects at the age between ≥18 and ≤80 years old; 2. patients with symptoms or evidence of myocardial ischaemia; 3. subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up after operation.
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 1. Any patient with myocardial infarction within one month; 2. 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%; 3. Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders; 4. 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; 5. Patients with severe renal failure(eGFR\<30ml/minute) or such medical history, failure to comply with angiography conditions; 6. Subjects who are intolerance or allergic to heparin, contrast agent, polyethylene oxide and polylactic acid - glycolic acid polymer; 7. Patients who plans to accept selective operation within 1 year; 8. Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint; 9. Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage diameter stenosis | 12 months |
Contacts
Primary Contactyaojun zhang, Ph.D.
Outcome results
None listed