AzTrials
AzTrials

Coronary Artery DiseaseNCT01808391

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)

An observational study of Coronary Artery Disease and Drug-eluting Stent, run by Associations for Establishment of Evidence in Interventions at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 20 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Coronary Artery Disease, Drug-eluting Stent
How many people
1,204 participants
Where
1 siteJapan
Study dates
Mar 2013to Apr 2016
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Non-profit organization Associations for Establishment of Evidence in Interventions

    Minato-ku, Tokyo, 105-0013

Other trials in Japan

About this study

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

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.

Keywords
Coronary artery disease, Heart disease, Myocardial ischemia, Cardiovascular disease, Arteriosclerosis, Vascular disease
Medical subject headings
Coronary Artery Disease, Heart Diseases, Myocardial Ischemia, Cardiovascular Diseases, Arteriosclerosis, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01808391
Study groupRoleWhat they receive
Clinical Follow-up CohortThe 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 CohortThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 12 months

Secondary outcomes (9)

  1. 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.

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

  2. Lesion success

    Lesion success defined as the attainment of a less than 50% residual stenosis by any percutaneous method.

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

  3. 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).

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

  4. TVF (target vessel failure)

    The composite of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.

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

  5. 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.

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

  6. Stent thrombosis

    Incidence of ARC-defined "definite" and "probable" stent thrombosis, and the combined incidence of "definite/probable" stent thrombosis.

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

  7. Duration of dual antiplatelet therapy

    Duration of DAPT after index PCI including the reason for interruption and discontinuation.

    Measured: 12, 24 and 36 months after index PCI

  8. Cerebrovascular accident

    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.

    Measured: 30 days, 6, 9, 12, 24 and 36 months afetr index PCI

  9. Procedure success

    The attainment of < 50%, residual stenosis of the target lesion and no in-hospital MACE as reported by the physician.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionMay 2014
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,204 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT01808391
Sponsor's protocol ID
PROPEL version 3.0 - AEEI
Status last verified
Jan 2017
First submitted
4 Mar 2013
Last updated
27 Jan 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Drug-eluting Stent, run by Associations for Establishment of Evidence in Interventions at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TLF (target lesion failure) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01808391.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2017; AzTrials last refreshed its copy on 30 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in