NCT03423511

Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries.

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,300 (estimated)
• Sponsor: Micell Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare MiStent to either the Xience or Promus stents.with 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 (1:1), 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	MiStent II coronary artery stent	Implantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction
DEVICE	Xience or Promus coronary artery stents	Implantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction

Timeline

• Start date: 2021-12-31
• Primary completion: 2023-06-01
• Completion: 2027-06-01
• First posted: 2018-02-06
• Last updated: 2020-09-04

Regulatory

• FDA-regulated device study