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.
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

March 4, 2013
March 8, 2013
March 2013
October 2014   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01808391 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
  • 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.
Same as current
 
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)
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

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.

Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
36 Months
Not Provided
Probability Sample

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.

  • Coronary Artery Disease
  • Drug-eluting Stent
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
October 2016
October 2014   (final data collection date for primary outcome measure)

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.
Both
20 Years to 85 Years
Yes
Contact: Masato Nakamura, M.D. +81.3.3468.1251
Japan
 
NCT01808391
PROPEL version 3.0 - AEEI
Yes
Associations for Establishment of Evidence in Interventions
Associations for Establishment of Evidence in Interventions
Medtronic Vascular
Principal Investigator: Masato Nakamura, MD Toho University Medical Center Ohashi Hospital
Associations for Establishment of Evidence in Interventions
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP