Status:
COMPLETED
A Prospective Multicenter Post Approval Study to Evaluate the Long-term Safety and Efficacy of the Resolute Integrity in the Japanese All-comers Patients With Coronary Artery Disease (PROPEL)
Lead Sponsor:
Associations for Establishment of Evidence in Interventions
Collaborating Sponsors:
Medtronic Vascular
Conditions:
Coronary Artery Disease
Drug-eluting Stent
Eligibility:
All Genders
20-85 years
Brief Summary
This is a prospective, multicenter, historical controlled study. The present clinical study will measure non-inferiority of 12 month TLF rate compared to historical control.The selected historical con...
Eligibility Criteria
Inclusion
- Patients aged 20 years or older.
- Patients with symptomatic coronary disease.
- Patients with a clinical indication for PCI and stenting of at least one coronary lesion, visually confirmed on coronary angiography.
- Patients who give informed consent to participate in this clinical study and sign the informed consent form approved by the institutional review board of each study site before the index PCI.
- Patients who agree to undergo all clinical follow-up procedures specified in the protocol for this clinical study.
- Patients in whom more than 50% occlusion or stenosis is visually confirmed in a native coronary artery with a diameter of 2.5 mm - 3.5 mm on coronary angiography and that has an anatomical structure suitable for PCI using Resolute Integrity zotarolimus-eluting stent.
Exclusion
- Patients aged 85 years or older.
- Patients with cardiogenic shock.
- Patients who are pregnant or possibly pregnant.
- Patients who cannot comply with the antiplatelet therapy specified for this clinical study.
- Patients scheduled to undergo elective surgery within 6 months post-index PCI.
- Patients with a history of allergic reaction or hypersensitivity to zotarolimus, sirolimus, tacrolimus, everolimus, or other analogues or derivatives.
- Patients with an allergic reaction to antiplatelet or anticoagulant drugs, such as heparin, aspirin, ticlopidine, or clopidogrel, or contrast agents, or those who cannot tolerate these substances and to whom appropriate treatments cannot be given.
- Patients with hypersensitivity to cobalt, nickel, chrome, molybdenum, coated polymer (e.g., BioLinx) contained in the materials of the study device or in whom these substances are specifically contraindicated.
- Patients who are currently participating in a clinical study of another drug or medical device and in whom assessment of the primary endpoint of that study has not been completed or clinically interferes with the endpoints of this clinical study.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
1204 Patients enrolled
Trial Details
Trial ID
NCT01808391
Start Date
March 1 2013
End Date
April 1 2016
Last Update
January 27 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Non-profit organization Associations for Establishment of Evidence in Interventions
Minato-ku, Tokyo, Japan, 105-0013