Coronary Artery Disease
Conditions
Keywords
Rotational atherectomy, Coronary dissection, Percutaneous coronary intervention, Calcification
Brief summary
This study is aimed at examining the safety and efficacy of rotational atherectomy (RA) in nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary intervention (PCI) procedure.
Detailed description
Coronary artery dissection is a contraindication for the use of rotational atherectomy, since rotational atherectomy may propagate coronary dissection. In the presence of coronary dissection, conservative management is suggested for approximately 4 weeks to permit the dissection to heal prior to treatment with rotational atherectomy. However, a lot of patients have frequent angina attacks and some patients develop serious complications including abrupt vessel closure during this period. Thus, immediate strategies cope with coronary dissection induced by balloon dilation is needed for the early recovery of those patients. The present study was performed to compare the safety and efficacy of immediate RA and delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.
Interventions
PROCEDUREImmediate rotational atherectomy (RA)
Immediate RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.
PROCEDUREDelayed rotational atherectomy (RA)
Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* age between 30 and 85 years old * nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary intervention (PCI) procedure * Coronary artery dissection type A, B and type C according to the National Heart, Lung and Blood Institute (NHLBI) coronary dissection criteria
Exclusion criteria
* acute myocardial infarction * unprotected left main stenosis * chronic total occlusion * saphenous vein graft lesion * cardiomyopathy * severe valvular heart disease * NYHA functional class IV heart failure at baseline * chronic renal failure on hemodialysis * severe lung and liver disease or cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All cause death | 4 years | cardiac death and non-cardiac death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-min walk distance (6MWD) | 4 years | — |
| angina class | 4 years | angina class according to the Canadian Cardiovascular Society (CCS) classification and Seattle Angina Questionnaire |
| Non-fatal myocardial infarction | 4 years | — |
| Stent thrombosis | 4 years | — |
| Left ventricular ejection fraction (LVEF) | 4 years | — |
| Stroke | 4 years | — |
| Target lesion revascularization | 4 years | — |
| New York Heart Association (NYHA) class IV heart failure | 4 years | — |
| Cardiac tamponade | 4 years | — |
Countries
China
Outcome results
None listed