Safety and Efficacy of the Combo Bio-engineered Sirolimus-eluting Stent Versus the Nano Polymer-free Sirolimus-eluting Stent in the Treatment of Patients With de Novo Stenotic Lesions

NACompletedINTERVENTIONAL
Enrollment

440

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

May 27, 2017

Study Completion Date

June 10, 2021

Conditions
Coronary Arteriosclerosis
Interventions
DEVICE

OrbusNeich Combo stent™

The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.

DEVICE

sirolimus-eluting stent system

Trial Locations (15)

Unknown

Daqing General Oilfield Hospital, Daqing

Jiangsu Province Hospital, Nanjing

Nanjing First Hospital, Nanjing

China Japan Union Hospital of Jilin University, Changchun

The people Hospital of Liaoning Province, Shenyang

The Secondary Affiliated Hospital of Shanxi Medical University, Taiyuan

West China Hospital of Sichuan University, Chengdu

Kunming General Hospital of Chengdu Military region, Kunming

Beijing Chao Yang Hospital, Beijing

The Military General Hospital of Beijing PLA, Beijing

Bethune International Peace Hospital, Shijiazhuang

TEDA International Cardiovascular Hospital, Tianjin

Tianjin Medical University General Hospital, Tianjin

Tianjing Chest Hospital, Tianjing

The First Affiliated Hospital of the Fourth Military Medical University, Xi'an, Shanxi

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

CCRF Inc., Beijing, China

INDUSTRY

collaborator

OrbusNeich Medical (Shenzhen), Co. Ltd.

INDUSTRY

lead

OrbusNeich

INDUSTRY

NCT02542007 - Safety and Efficacy of the Combo Bio-engineered Sirolimus-eluting Stent Versus the Nano Polymer-free Sirolimus-eluting Stent in the Treatment of Patients With de Novo Stenotic Lesions | Biotech Hunter | Biotech Hunter