NCT01909869

A Pilot First In Man Study of EXCEL-Ⅱto Treat the Patients With de Novo Coronary Artery Lesions

A PILOT First-In-Man Study to Evaluate Safety and Efficacy of the EXCEL-Ⅱ With Cobalt Chromium Alloys Sirolimus Eluting Biodegradable Polymer Stent in the Treatment of Patients With de Novo Coronary Artery Lesions(CREDIT-I)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: JW Medical Systems Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

One of the purpose of this study is to assess the preliminary safety and feasibility,and to provide related information and evidence for the design of the further pivotal randomized control trial.the other purpose is to assess the performace of the stent delivery system.

Detailed description

1. Single-center, prospective, pilot study 2. De novo,coronary artery, single vessel and single lesion 3. Sample size = 45 4. Follow- up clinical or phone at 1-month,9-month and annually 2 to 5 years 5. Randomization 2:1 Angio and OCT scheduled follow-up in the hospital 6. Follow-up Angio and OCT randomized 30 patients for 4-month and 15 patiens for 12-month

Conditions

• Ischemia
• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	EXCEL-Ⅱ	A PILOT First-In-Man Study to evaluate safety and efficacy of the EXCEL-Ⅱ with New Cobalt ChRomium Alloys Sirolimus Eluting BioDegradable Polymer Stent In the Treatment of Patients with de novo Coronary Artery Lesions

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-09-01
• Completion: 2019-06-04
• First posted: 2013-07-29
• Last updated: 2023-04-26

Locations

1 site across 1 country: China