Overview

This trial is active, not recruiting.

Conditions coronary artery disease, drug-eluting stent
Phase phase 4
Sponsor Associations for Establishment of Evidence in Interventions
Collaborator Medtronic Vascular
Start date March 2013
End date May 2014
Trial size 1200 participants
Trial identifier NCT01808391, PROPEL version 3.0 - AEEI

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
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.

Primary Outcomes

Measure
TLF (target lesion failure)
time frame: 12 months

Secondary Outcomes

Measure
Delivery success
time frame: stent implantation until hospital discharge (average 1-5 days)
Lesion success
time frame: stent implantation until hospital discharge (average 1-5 days)
TLF (target lesion failure)
time frame: 30 days, 6, 9, 12, 24 and 36 months after index PCI
TVF (target vessel failure)
time frame: 30 days, 6, 9, 12, 24 and 36 months after index PCI
MACE (major adverse cardiac event)
time frame: 30 days, 6, 9, 12, 24 and 36 months after index PCI
Stent thrombosis
time frame: 30 days, 6, 9, 12, 24 and 36 months after index PCI
Duration of dual antiplatelet therapy
time frame: 12, 24 and 36 months after index PCI
Cerebrovascular accident
time frame: 30 days, 6, 9, 12, 24 and 36 months afetr index PCI
Procedure success
time frame: stent implantation until hospital discharge (average 1-5 days)

Eligibility Criteria

Male or female participants from 20 years up to 85 years old.

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.

Additional Information

Official title 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
Principal investigator Masato Nakamura, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Associations for Establishment of Evidence in Interventions.