Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent (CREATE)

JW Medical Systems

Status and phase: Completed; Phase 4

Conditions: AMI

Treatments: Device: Excel drug-eluting coronary artery stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00331578

H-06-6

Details and patient eligibility

About

The trial aims to evaluate 12-month long-term efficiency of Excel stent in the treatment of coronary heart disease and inhibition of restenosis after coronary artery stenting as well as a 12 months' long-term safety after the cessation of clopidogrel as an anti-platelet drugs used for 6 months after the implantation of degradable drug coating stent.

Enrollment: 2,077 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient who should be full fill the criteria of using Excel stent.
2. Each included patient should allowed to use Excel stent.
3. Complete revascularization can be achieved through one invasive operation.

Exclusion criteria

1. Patient do not suitable to use Excel stent, for example, not tolerant to anti-platelet drug or undergo cardiac/non-cardiac surgery recently.
2. Patient with multiple branch lesions, thus the single Excel stent cannot resolve the condition.
3. NYH Cardiac functional grading>3 or Echocardiography LVEF<0.3.
4. Patient with complete revascularization cannot be resolved by one operation.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)