Ignite Creation Date:
2024-05-06 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03423511
Status:
NOT_YET_RECRUITING
Last Update Posted:
2020-09-04
First Post:
2018-01-23
Brief Title:
Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries
Sponsor:
Micell Technologies
Organization:
Micell Technologies
Study Overview
Official Title:
CRYSTAL Study A Multi-Center Randomized Controlled Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries
Status:
NOT_YET_RECRUITING
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRYSTAL
Brief Summary:
To compare MiStent to either the Xience or Promus stentswith the primary objective being to assess the safety and efficacy of the MiStent in a patient population requiring revascularization of de novo obstructive lesions of coronary arteries in patients with stable and unstable coronary artery disease CAD including non ST-Elevation Myocardial Infarction NSTEMI
Detailed Description:
The CRYSTAL study is a prospective multi-center randomized 11 single-blinded and controlled investigational device exemption trial to test the non-inferiority of MiStent to commercially available everolimus drug eluting stents Xience and Promus stents
Patients with coronary artery disease CAD that qualify for percutaneous coronary intervention PCI with stenting will be screened per the protocol inclusion and exclusion criteria
Patients with coronary artery disease CAD that qualify for percutaneous coronary intervention PCI with stenting will be screened per the protocol inclusion and exclusion criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None