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)

NCT01808391 | Completed DMC

• 1 other identifier: PROPEL version 3.0 - AEEI
• Study Type: observational
• Target: 1,204
• Locations: 1 country
• Sites: 1

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

Keywords

Coronary artery disease; Heart disease; Myocardial ischemia; Cardiovascular disease; Arteriosclerosis; Vascular disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Delivery success

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

• Lesion success

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

• TLF (target lesion failure)

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

• TVF (target vessel failure)

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

• MACE (major adverse cardiac event)

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

Other Outcomes (2)

• 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

• Evaluation of medical economics

  24 months after index PCI

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Among 1,200 patients to be registered at the website database, the first 900 continuously registered patients will be then assigned to the clinical follow-up cohort, and the remaining 300 patients to the routine angiographic follow-up cohort.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Associations for Establishment of Evidence in Interventions: lead
• Medtronic Vascular: collaborator

Study Sites (1)

Non-profit organization Associations for Establishment of Evidence in Interventions

Minato-ku, Tokyo, 105-0013, Japan

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Diseases; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Vascular Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Arterial Occlusive Diseases

Study Officials

• Masato Nakamura, MD

  Toho University Medical Center Ohashi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: March 11, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: April 1, 2016
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

JP (1)