FrActional Flow Reserve Guided Drug Coated Balloon Only Strategy in De Novo coronarY Lesions (FADDY) (FADDY)

March 21, 2018 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

The Randomized FADDY Study (FrActional Flow Reserve Guided Drug Coated Balloon Only Strategy in De Novo coronarY Lesions)

Drug-eluting stent (DES) has been the primary choice for in suit coronary lesions treatment. In comparison to bare-metal stent (BMS), it evidently decreases the rate of restenosis. However, in recent years in-stent restenosis or thrombogenesis caused by acquired stent malapposition in the late stage or by new in-stent atherosclerotic plaques was oberved, which possibly was associated with chronic inflammation stimulation because of residual intravascular metal or polymer coating. Through being expanded around 30 to 60 seconds, drug-coated balloon (DCB) can ensure adequate paclitaxel enter the artery wall, which can inhibit smooth muscle cells hyperplasia without remaining any foreign body. In recent small sample trials, they showed that sole DCB treatment had a good long-term effect when pre-treating ideal in suit coronary lesions (defined as residual stenosis< 30%, without dissection severer than type C, anterograde flow TIMI III). In PEPCAD I trial, the rate of major adverse cardiovascular events (MACE) was 6.1% in the first 12 months and persistent to 3-year follow up. Small sample prospective observational study from Korea, like Shin, showed that in the in suit coronary lesions with the fractional flow reserve (FFR)>0.85 after percutaneous transluminal coronary angioplasty (PTCA), the FFR kept unchanged in the 9-month follow up after DCB treatment and there was not MACE happened. However, so far randomized controlled trials with large sample to confirm their non-inferiority compared with DES when treating relatively larger in suit coronary lesions are lacked. Meanwhile, a number of doctors worried about acute cardiovascular occlusion and long-term restenosis. In this study, we assume that in the in suit coronary lesions with FFR>0.85 after PTCA pre-treatment, DCB treatment is not inferior to DES treatment regarding to middle- and long-term functional recovery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical Criteria:

    1. Patients with age >= 18 years old
    2. Patients with coronary artery disease is confirmed by angiography
    3. Patients with angina (CCS class II-IV) or documented ischemia evidence with ECG or ECT
    4. Patients agree to sign the informed consent

  • Angiographic Criteria:

    1. In suit coronary lesions
    2. Reference diameters of target vessels by visual estimation from 2.5 mm to 3.5 mm and < 28 mm in length
    3. Lesion diameter stenosis >= 70% by visual estimation or >= 50% with objective ischemia evidence (exercise stress testing, ECT or FFR< 0.8)

Exclusion Criteria:

  • Clinical Criteria:

    1. Patients with STEMI <= 1 week
    2. Patients with LVEF < 30%
    3. Patients with bleeding diathesis or known anticoagulation dysfunction
    4. Patients with medical history regarding of intracranial tumor, aneurysm, arteriovenous malformation or cerebral apoplexy; stroke or TIA within 6 months; gastrointestinal hemorrhage within 2 months; major surgery within 6 weeks; recent or known platelet < 100,000/mm3 or hemoglobin < 10 g/dL
    5. Patients with planed selective operation probably leading to stopping using ADP receptor antagonists in advance
    6. Patients with life expectancy is less than 1 year because of combined comorbidity of other system

  • Angiographic Criteria:

    1. Acute thrombotic lesions
    2. Left main coronary artery lesions
    3. Severe intima tear lesions
    4. Coronary artery bypass grafts lesions
    5. In-stent restenosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Drug-coated balloon
Treatment of in suit coronary lesions with drug-coated balloon
Device: Drug-coated balloon
Treatment of in suit coronary lesions with drug-coated balloon
Active Comparator: Drug-eluting stent
Treatment of in suit coronary lesions with drug-eluting stent
Device: Drug-eluting stent
Treatment of in suit coronary lesions with drug-eluting balloon

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
9-month fractional flow reserve value
Time Frame: 9 months
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Late lumen loss
Time Frame: 9 months
9 months
Percent restenosis
Time Frame: 9 months
9 months
Failure rate of target lesions
Time Frame: 9 months
9 months
Rate of thrombosis in target lesions
Time Frame: 9 months
9 months
Cumulative MACE rate
Time Frame: 9 months
9 months
Success rate of the strategy
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ningbo No. 1 Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jian-an Wang, MD,PhD, Second Affiliated Hospital of Zhejiang University, School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAHZJU CT008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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