immediate incomplete stent expansion or restenosis caused by previous incomplete stent expansion
Conditions
Interventions
Experimental group:conventional therapy+ Shockwave catheter
Control group:Conventional therapy(non compliant balloon, modification balloon, rotablator)
Sponsors
Liaoning Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1.Age >=18 years, gender unrestricted; 2.Patients with inadequate expansion of the stent balloon at a ratio of less than 1:1 or confirmed by IVUS examination to have insufficient stent expansion (minimum stent area/reference vessel area <=80%), including those with immediate incomplete stent expansion or restenosis caused by previous incomplete stent expansion; 3.Target vessel diameter ranging from 2.5 mm to 4.0 mm (estimated); 4.Target lesion length <=40mm (estimated); 5.Presence of up to two target lesions located in different target vessels; 6.Subjects voluntarily participate in the trial and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1.Patients with excessively curved target vessels that hinder the smooth passage of guidewire or IVUS catheter; 2.Patients classified as NYHA functional class IV or with left ventricular ejection fraction (LVEF) 3 times the upper limit of normal), severe renal failure (serum creatinine >2.5 mg/dL), or requiring long-term dialysis; 6.Patients who had symptomatic stroke within the past six months (excluding transient ischemic attack [TIA]); 7.Patients who had active gastrointestinal ulcers or upper gastrointestinal bleeding within the past six months; 8.Preoperative hemoglobin 1.7(including only patients taking warfarin within14 days before enrollment); 10.Patient in cardiogenic shock; 11.Patient expected to have a lifespan less than one year; 12.Patient allergic to contrast agents or balloon materials; 13.Isolated thrombotic lesions,or single coronary artery supply lesion; 14.Bridge vessel lesions; 15.The target lesion exhibits severe dissection of type C or higher; 16.Pregnant or lactating women; 17.Patients who are participating in clinical trials of other drugs or medical devices; 18.Other patients judged by the investigator to be unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Clinical success rate;The internal area of the target lesion stent increased;Target lesion relative stent expansion rate; | — |
Countries
China
Contacts
Public ContactBo Luan
Liaoning Provincial People's Hospital
Outcome results
None listed