Feasibility and Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Elective PCI

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if it is feasible and safe to use the REG1 Anticoagulation System instead of unfractionated heparin during percutaneous coronary intervention (PCI) in subjects with coronary artery disease (CAD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regado Biosciences, Inc.
• Treatments: Calcium heparin; Heparin

Criteria

Inclusion Criteria:

• Males or females scheduled for non-urgent elective PCI (who do not have certain cardiac parameters) and have not been treated with UHF prior to PCI.

• Subject able to give informed consent and comply with the protocol.

• Negative urine pregnancy test or documented surgical sterilization or menopausal.

Exclusion Criteria:

• Subject weight >120 kg.

• Recent acute coronary syndrome with elevated cardiac markers or ST segment depression at rest.

• Evidence of clinical instability

• Angiographic high-risk.

• A contraindication to anticoagulation or increased risk of bleeding.

• Use of prohibited medications or investigational drugs prior to the study.

• Clinically significant abnormal laboratory findings.

• Planned use of femoral sheath greater than a certain size.

• Known allergy or intolerance to drugs mandated by the study.

• Use of devices other than angioplasty balloons and coronary stents.

• A history of licit drug abuse or illicit drug use or current evidence of such abuse.

• Any other factor that the Investigator feels would put the subject at increased risk if participating in the protocol.

• Lactation.

• Currently enrolled in this or another clinical trial (with some exceptions).

• Participation in an investigational drug or device trial in the past 30 days.