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)

NCT ID: NCT01808391

Last Updated: 2017-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1204 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-04-30

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 control is the Xience V arm from RESOLUTE All-Comer clinical study, that study is a prospective, multicenter, randomized, two-arm, international, open-label study.The historical control did not have angiographic follow up before 12 months, in the present clinical study, only subjects with clinical follow-up conducted at 12 months without any pre-specified angiographic assessment prior to 12 month clinical follow-up will be part of this analysis cohort. Out of the total 1200 patients, 900 patients (clinical follow-up cohort) will be included in this analysis cohort.

Conditions

Coronary Artery Disease; Drug-eluting Stent

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Clinical Follow-up Cohort

The clinical FU cohort comprises among patients who underwent clinical FU at 9, 12, and 24 months after index PCI those who arbitrarily underwent angiographic FU at 22 months (±60 days) after index PCI and those who did not undergo angiographic follow-up at all during the entire study period.

No interventions assigned to this group

Routine Angiographic Follow-up Cohort

The routine angiographic FU cohort comprises patients who underwent clinical FU at 9, 12, and 24 months after index PCI those who undergo angiographic FU at 10 months (±60 days) after index PCI.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic Vascular

INDUSTRY

Sponsor Role: collaborator

Associations for Establishment of Evidence in Interventions

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Masato Nakamura, MD

Role: PRINCIPAL_INVESTIGATOR

Toho University Medical Center Ohashi Hospital

Locations

Non-profit organization Associations for Establishment of Evidence in Interventions

Minato-ku, Tokyo, , Japan

Countries

Japan

Other Identifiers

PROPEL version 3.0 - AEEI

Identifier Type: -

Identifier Source: org_study_id