NCT04985773

A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon

A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon (EXPANSE-PTCA)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Infraredx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate safety and effectiveness of the Lacrosse NSE ALPHA coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.

Detailed description

The investigation is a prospective, multi-center, single arm clinical study. The study will be conducted in up to 15 investigational sites in the U.S. This study will enroll and treat 200 subjects, including a minimum of 30 subjects with in-stent restenosis (ISR). The population for this study is subjects with stenotic coronary artery disease who are suitable candidates for PTCA. After screening for initial inclusion and exclusion criteria, eligible subjects will be asked to participate in the study by signing a consent form. Following consent, subjects will undergo a baseline visit where additional eligibility criteria will be assessed. An angiogram will be completed to assess for angiographic eligibility. If a non-target lesion is identified, it must be treated successfully prior to target lesion treatment. Once treatment of the target lesion(s) has been attempted, the subject will be considered enrolled in the study. Subjects will be followed through hospital discharge.

Conditions

• Coronary Stenosis
• Coronary Artery Stenosis
• In-stent Restenosis

Interventions

Type	Name	Description
DEVICE	Lacrosse NSE ALPHA coronary dilatation catheter	The Lacrosse NSE ALPHA is a rapid exchange percutaneous transluminal coronary angioplasty balloon catheter with non-slip element nylon threads that focus dilatation force to reduce balloon slippage during inflation.

Timeline

• Start date: 2021-12-17
• Primary completion: 2022-12-16
• Completion: 2022-12-16
• First posted: 2021-08-02
• Last updated: 2024-01-12
• Results posted: 2024-01-12

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study