Trials / Completed
CompletedNCT01701596
Safety and Efficacy of Rotational Atherectomy (RA) in Coronary Dissection
Safety and Efficacy of Immediate Rotational Atherectomy in Nondilatable Calcified Lesion Complicated by Coronary Dissection (RAISE)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 198 (actual)
- Sponsor
- Xijing Hospital · Academic / Other
- Sex
- All
- Age
- 30 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Immediate rotational atherectomy (RA) | Immediate RA in the treatment with nondilatable calcified lesion complicated by coronary dissection. |
| PROCEDURE | Delayed rotational atherectomy (RA) | Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection |
Timeline
- Start date
- 2004-08-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2012-10-05
- Last updated
- 2014-08-20
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01701596. Inclusion in this directory is not an endorsement.