NCT01092416

Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions

Pivotal Trial to Evaluate the Safety and Efficacy of the Diamondback 360°® Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions (ORBIT II)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 443 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, multi-center study to evaluate the safety and performance of the OAS in treating de novo, severely calcified coronary lesions in adult subjects. Study is going to enroll up to 429 subjects in up to 50 U.S. study sites. The primary safety endpoint is 30-day MACE and primary efficacy endpoint is procedural success. All subjects will be treated with the orbital atherectomy system and adjunctive stent. All subjects will be followed in clinic at 30 days. Additionally, all subjects will have an annual phone call or clinical follow up at each anniversary until study is closed.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Diamondback 360 Orbital Atherectomy System	Diamondback 360 Orbital Atherectomy System. The (OAS) utilizes a diamond-coated eccentric crown that, while rotating over an atherectomy guide wire, expands the lumen diameter laterally via centrifugal forces (up to a maximum orbit diameter for a given rotational speed and crown diameter). It is a minimally invasive PCI procedure.

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-01-01
• Completion: 2016-01-01
• First posted: 2010-03-25
• Last updated: 2023-07-18
• Results posted: 2016-01-06

Locations

51 sites across 1 country: United States