Clinical trial NCT01808391: 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)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Drug-eluting Stent
Keywords: Coronary artery disease
Heart disease
Myocardial ischemia
Cardiovascular disease
Arteriosclerosis
Vascular disease
Lead sponsor: Associations for Establishment of Evidence in Interventions
Sponsor class: OTHER
Collaborators: name: Medtronic Vascular
First posted: 2013-03-11
Enrollment: 1204
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: TLF (target lesion failure)
timeFrame: 12 months
Secondary outcomes:
measure: Delivery success
timeFrame: stent implantation until hospital discharge (average 1-5 days)
measure: Lesion success
timeFrame: stent implantation until hospital discharge (average 1-5 days)
measure: TLF (target lesion failure)
timeFrame: 30 days, 6, 9, 12, 24 and 36 months after index PCI
measure: TVF (target vessel failure)
timeFrame: 30 days, 6, 9, 12, 24 and 36 months after index PCI
measure: MACE (major adverse cardiac event)
timeFrame: 30 days, 6, 9, 12, 24 and 36 months after index PCI
measure: Stent thrombosis
timeFrame: 30 days, 6, 9, 12, 24 and 36 months after index PCI
measure: Duration of dual antiplatelet therapy
timeFrame: 12, 24 and 36 months after index PCI
measure: Cerebrovascular accident
timeFrame: 30 days, 6, 9, 12, 24 and 36 months afetr index PCI
measure: Procedure success
timeFrame: stent implantation until hospital discharge (average 1-5 days)
Other outcomes:
measure: 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.
timeFrame: 24 months after index PCI
measure: Evaluation of medical economics
timeFrame: 24 months after index PCI
Locations:
city: Minato-ku, Tokyo
country: Japan
facility: Non-profit organization Associations for Establishment of Evidence in Interventions
Study officials:
affiliation: Toho University Medical Center Ohashi Hospital
name: Masato Nakamura, MD
role: PRINCIPAL_INVESTIGATOR
References: