Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotational atherectomy (RA) | Experimental | Immediate rotational atherectomy (RA) in the treatment with nondilatable calcified lesion complicated by coronary dissection |
|
| Delayed rotational atherectomy (RA) | Active Comparator | Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate rotational atherectomy (RA) | Procedure | Immediate RA in the treatment with nondilatable calcified lesion complicated by coronary dissection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| All cause death | cardiac death and non-cardiac death | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction (LVEF) | 4 years | |
| 6-min walk distance (6MWD) | 4 years | |
| angina class |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chengxiang Li, M.D., Ph.D. | Department of Cardiolody, Xijing Hospital, Fourth Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital, Fourth Military Medical University | Xi'an | Shaanxi | 710032 | China |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002114 | Calcinosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Delayed rotational atherectomy (RA) | Procedure | Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection |
|
angina class according to the Canadian Cardiovascular Society (CCS) classification and Seattle Angina Questionnaire
| 4 years |
| Non-fatal myocardial infarction | 4 years |
| Stent thrombosis | 4 years |
| Cardiac tamponade | 4 years |
| Stroke | 4 years |
| Target lesion revascularization | 4 years |
| New York Heart Association (NYHA) class IV heart failure | 4 years |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |