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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Associations for Establishment of Evidence in Interventions
Sponsor:
Collaborator:
Medtronic Vascular
Information provided by (Responsible Party):
Associations for Establishment of Evidence in Interventions
ClinicalTrials.gov Identifier:
NCT01808391
First received: March 4, 2013
Last updated: March 8, 2013
Last verified: March 2013
  Purpose

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.


Condition Phase
Coronary Artery Disease
Drug-eluting Stent
Phase 4

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
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

Further study details as provided by Associations for Establishment of Evidence in Interventions:

Primary Outcome Measures:
  • TLF (target lesion failure) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Delivery success [ Time Frame: stent implantation until hospital discharge (average 1-5 days) ] [ Designated as safety issue: Yes ]

    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.


  • Lesion success [ Time Frame: stent implantation until hospital discharge (average 1-5 days) ] [ Designated as safety issue: Yes ]
    Lesion success defined as the attainment of a less than 50% residual stenosis by any percutaneous method.

  • TLF (target lesion failure) [ Time Frame: 30 days, 6, 9, 12, 24 and 36 months after index PCI ] [ Designated as safety issue: Yes ]
    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).

  • TVF (target vessel failure) [ Time Frame: 30 days, 6, 9, 12, 24 and 36 months after index PCI ] [ Designated as safety issue: Yes ]
    The composite of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.

  • MACE (major adverse cardiac event) [ Time Frame: 30 days, 6, 9, 12, 24 and 36 months after index PCI ] [ Designated as safety issue: Yes ]
    All-cause death, myocardial infarction (QWMI and NQWMI), emergency coronary artery bypass graft(CABG), or TLR by medical or surgical procedure.

  • Stent thrombosis [ Time Frame: 30 days, 6, 9, 12, 24 and 36 months after index PCI ] [ Designated as safety issue: Yes ]
    Incidence of ARC-defined "definite" and "probable" stent thrombosis, and the combined incidence of "definite/probable" stent thrombosis.

  • Duration of dual antiplatelet therapy [ Time Frame: 12, 24 and 36 months after index PCI ] [ Designated as safety issue: No ]
    Duration of DAPT after index PCI including the reason for interruption and discontinuation.

  • Cerebrovascular accident [ Time Frame: 30 days, 6, 9, 12, 24 and 36 months afetr index PCI ] [ Designated as safety issue: Yes ]
    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.

  • Procedure success [ Time Frame: stent implantation until hospital discharge (average 1-5 days) ] [ Designated as safety issue: Yes ]
    The attainment of < 50%, residual stenosis of the target lesion and no in-hospital MACE as reported by the physician.


Other Outcome Measures:
  • 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. [ Time Frame: 24 months after index PCI ] [ Designated as safety issue: Yes ]
  • Evaluation of medical economics [ Time Frame: 24 months after index PCI ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1200
Study Start Date: March 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01808391

Contacts
Contact: Masato Nakamura, M.D. +81.3.3468.1251

Locations
Japan
Non-profit organization Associations for Establishment of Evidence in Interventions Recruiting
Minato-ku, Tokyo, Japan, 105-0013
Contact: Masato Nakamura, M.D.    +81.3.3468.1251      
Principal Investigator: Masato Nakamura, M.D.         
Sponsors and Collaborators
Associations for Establishment of Evidence in Interventions
Medtronic Vascular
Investigators
Principal Investigator: Masato Nakamura, MD Toho University Medical Center Ohashi Hospital
  More Information

No publications provided

Responsible Party: Associations for Establishment of Evidence in Interventions
ClinicalTrials.gov Identifier: NCT01808391     History of Changes
Other Study ID Numbers: PROPEL version 3.0 - AEEI
Study First Received: March 4, 2013
Last Updated: March 8, 2013
Health Authority: Japan: Institutional Review Board

Keywords provided by Associations for Establishment of Evidence in Interventions:
Coronary artery disease
Heart disease
Myocardial ischemia
Cardiovascular disease
Arteriosclerosis
Vascular disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014