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)

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.

Full record on ClinicalTrials.gov (NCT ID NCT01092416).

Full results record on ClinicalTrials.gov.

Phase

Phase None

Study type

Interventional

Masking

Open label

Intervention model

Single group assignment

Primary purpose

Treatment

Enrollment (final)

443 participants

Actually completed

January 2016

Age range: ≥ 18 · Sex: All · Healthy volunteers: Requires diagnosis

51 sites participated during the trial period. Representative sites shown below; full historical record on ClinicalTrials.gov.