NCT03574636

OCT vs IVUS vs QCA to Guide Moderate-to-severe Calcified Lesion Stent Implantation

Optical Coherence Tomography Compared With Intravascular Ultrasound or Quantitative Coronary Analysis to Guide Stent Implantation in the Treatment of Moderate-to-severe Calcified Lesion in Coronary Artery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multi-center, randomized controlled clinical trial, aims to assess the safety and effectiveness of Optical Coherence Tomography or Intravascular Ultrasound or Quantitative Coronary Analysis to guide Firehawk stent implantation , and compared the treatment of moderate-to-severe calcified lesion in coronary artery.

Detailed description

This clinical trial will enroll 375 subjects and assign to groups in a 1:1:1 ratio (base on Intravascular Ultrasound \[IVUS\]-guided treatment group : Optical Coherence Tomography \[OCT\]-guided treatment group : Quantitative Coronary Angiography \[QCA\]-guided treatment group) who have moderate-severe calcified lesions in de novo native coronary artery with ≥2.50 mm to ≤4.00 mm in diameter (visual measurement) from a maximum of 25 study sites in China. After the stent is implanted satisfactorily, OCT examinations will be performed on the subjects of these three groups to observe stent expansion after implantation. At 13 months after procedure, all subjects will receive QCA examination. OCT sub-group study: The initial 66 ongoing subjects from the three treatment groups (IVUS-guided treatment group : OCT-guided treatment group : QCA-guided treatment group) who provided informed consent and successfully randomized will receive OCT examinations at three months follow up after baseline procedure.

Conditions

• Optical Coherence Tomography
• Intravascular Ultrasound
• Angiography

Interventions

Type	Name	Description
DEVICE	OCT guidance	OCT guide stent implantation
DEVICE	IVUS guidance	IVUS guide stent implantation
DEVICE	QCA	QCA guide stent implantation

Timeline

• Start date: 2019-10-18
• Primary completion: 2021-09-01
• Completion: 2025-09-01
• First posted: 2018-07-02
• Last updated: 2020-01-13

Locations

1 site across 1 country: China