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)

Associations for Establishment of Evidence in Interventions1,204 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,204

Conditions

Coronary Artery Disease Drug-eluting Stent

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

TLF (target lesion failure)

The composite of Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel) or Target Lesion Revascularization (TLR; clinically indicated) (= device oriented endpoint).

Time frame: 12 months

Secondary Outcomes

Delivery success

Complete passage of the stent across the target lesion with full expansion of the stent to the desired diameter at the desired location. Note: Failed delivery: failure to pass the stent through the guiding catheter into the coronary artery,failure to pass it completely across the target lesion, or failure to expand the stent to its desired diameter. Failed delivery includes proximal deployment defined as those instances of failed delivery when the stent could be advanced only partially across the target lesion but was deployed nonetheless by full expansion.

Time frame: stent implantation until hospital discharge (average 1-5 days)

Lesion success

Lesion success defined as the attainment of a less than 50% residual stenosis by any percutaneous method.

Time frame: stent implantation until hospital discharge (average 1-5 days)

TLF (target lesion failure)

The composite of Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel) or Target Lesion Revascularization (TLR; clinically indicated) (= device oriented endpoint).

Time frame: 30 days, 6, 9, 12, 24 and 36 months after index PCI

TVF (target vessel failure)

The composite of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.

Time frame: 30 days, 6, 9, 12, 24 and 36 months after index PCI

MACE (major adverse cardiac event)

All-cause death, myocardial infarction (QWMI and NQWMI), emergency coronary artery bypass graft(CABG), or TLR by medical or surgical procedure.

Time frame: 30 days, 6, 9, 12, 24 and 36 months after index PCI

Stent thrombosis

Incidence of ARC-defined "definite" and "probable" stent thrombosis, and the combined incidence of "definite/probable" stent thrombosis.

Time frame: 30 days, 6, 9, 12, 24 and 36 months after index PCI

Duration of dual antiplatelet therapy

Duration of DAPT after index PCI including the reason for interruption and discontinuation.

Time frame: 12, 24 and 36 months after index PCI

Cerebrovascular accident

1. Neurological disorder that appears rapidly and persists for at least 24 hours, and is attributable to a reduction in the cerebrovascular blood flow due to bleeding or ischemia. 2. If an AE due to CVA occurs, it is desirable to obtain diagnostic imaging findings constituting evidence or a diagnosis by a specialist. 3. TIA of which the symptoms disappear within 24 hours is not CVA.

Time frame: 30 days, 6, 9, 12, 24 and 36 months afetr index PCI

Procedure success

The attainment of \< 50%, residual stenosis of the target lesion and no in-hospital MACE as reported by the physician.

Time frame: stent implantation until hospital discharge (average 1-5 days)

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)

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes