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)

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808391
• Other study ID #: PROPEL version 3.0 - AEEI
• Status: Completed
• Phase: N/A
• First received: March 4, 2013
• Last updated: January 26, 2017
• Start date: March 2013
• Est. completion date: April 2016

Study information

• Verified date: January 2017
• Source: Associations for Establishment of Evidence in Interventions
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1204
• Est. completion date: April 2016
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Drug-eluting Stent
• Myocardial Ischemia

Locations

Country	Name	City	State
Japan	Non-profit organization Associations for Establishment of Evidence in Interventions	Minato-ku, Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Associations for Establishment of Evidence in Interventions	Medtronic Vascular

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of long-term clinical outcomes due to a difference in follow-up procedure (clinical follow-up or routine angiographic follow-up) after index PCI.		24 months after index PCI
Other	Evaluation of medical economics	The objectives of this clinical study are to 1) assess the efficacy and safety of RI-ZES at 10 and 22 months (±60 days) after index PCI for routine angiographic FU after index PCI and to 2) investigate its medical costs.	24 months after index PCI
Primary	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).	12 months
Secondary	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.	stent implantation until hospital discharge (average 1-5 days)
Secondary	Lesion success	Lesion success defined as the attainment of a less than 50% residual stenosis by any percutaneous method.	stent implantation until hospital discharge (average 1-5 days)
Secondary	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).	30 days, 6, 9, 12, 24 and 36 months after index PCI
Secondary	TVF (target vessel failure)	The composite of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.	30 days, 6, 9, 12, 24 and 36 months after index PCI
Secondary	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.	30 days, 6, 9, 12, 24 and 36 months after index PCI
Secondary	Stent thrombosis	Incidence of ARC-defined "definite" and "probable" stent thrombosis, and the combined incidence of "definite/probable" stent thrombosis.	30 days, 6, 9, 12, 24 and 36 months after index PCI
Secondary	Duration of dual antiplatelet therapy	Duration of DAPT after index PCI including the reason for interruption and discontinuation.	12, 24 and 36 months after index PCI
Secondary	Cerebrovascular accident	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.; If an AE due to CVA occurs, it is desirable to obtain diagnostic imaging findings constituting evidence or a diagnosis by a specialist.; TIA of which the symptoms disappear within 24 hours is not CVA.	30 days, 6, 9, 12, 24 and 36 months afetr index PCI
Secondary	Procedure success	The attainment of < 50%, residual stenosis of the target lesion and no in-hospital MACE as reported by the physician.	stent implantation until hospital discharge (average 1-5 days)