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A Comparison Between FFR Guided and CAG Guided Treatment Using DEB in ISR of DES

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ClinicalTrials.gov Identifier: NCT04518826
Recruitment Status : Not yet recruiting
First Posted : August 19, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Study Description
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Brief Summary:
This is a prospective single center, randomized controlled clinical study aimed to compare the clinical and angiographic follow-up results of patients with in-stent restenosis(ISR) after coronary drug eluting stent(DES) implantation treated by fractional flow reserve -guided and angiography guided drug eluting balloon(DEB) intervention. This study intends to confirm the clinical benefits of optimizing DEB intervention of DES-ISR by FFR.

Condition or disease Intervention/treatment
In Stent Restenosis Drug Eluting Stent Coronary Artery Disease Device: fractional flow reserve

Detailed Description:
420 patients with DES-ISR will be recruited in this study. After angiography, patients with DES-ISR to be treated with DEB will be randomly assigned to FFR-guided and angiography-guided groups. In FFR group, FFR at maximum hyperemia will be measured after pretreatment of DES-ISR lesion by balloons(non-compliant balloon, cutting balloon or scoring balloon). If FFR <0.9, the operator will dilate the DES-ISR lesion again before another FFR is measured. If FFR>=0.9, DEB will be used and final FFR will be measured at the end of the procedure. In angiography group, the operator will treat the DES-ISR lesion with balloons(non-compliant balloon, cutting balloon or scoring balloon), and then DEB without FFR guidance.
Study Design
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Study Type : Observational
Estimated Enrollment : 420 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Comparison Between Fractional Flow Reserve Guided and Coronary Angiography Guided Treatment Using Drug Eluting Balloon in In-stent Restenosis of Drug Eluting Stent: a Single-center, Prospective, Randomized Controlled Clinical Trial
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
FFR
In FFR group, FFR at maximum hyperemia will be measured after pretreatment of DES-ISR lesion by balloons(non-compliant balloon, cutting balloon or scoring balloon). If FFR <0.9, the operator will dilate the DES-ISR lesion again before another FFR is measured. If FFR>=0.9, DEB will be used and final FFR will be measured at the end of the procedure.
 Device: fractional flow reserve
FFR is a physiological functional parameter indicating the severity of ischemic myocardium perfused by a diseased coronary artery. It is measured by a pressure wire placed in the coronary artery and calculated by the ratio of pressures distal and proximal to the stenosis.
CAG
In angiography group, the operator will treat the DES-ISR lesion with balloons(non-compliant balloon, cutting balloon or scoring balloon), and then DEB without FFR guidance.


Outcome Measures
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Primary Outcome Measures :
  1. target vessel failure [ Time Frame: 12 month ]
    cardiac death, target vessel myocardial infarction, target vessel failure


Secondary Outcome Measures :
  1. angiographic outcomes [ Time Frame: 12 month ]
    diameter stenosis, binary stenosis and late lumen loss measured by QCA

  2. target vessel failure [ Time Frame: 36 month ]
    cardiac death, target vessel myocardial infarction, target vessel failure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with coronary artery disease and DES implantation.
Criteria

Inclusion Criteria:

In-stent restenosis(ISR) occurred more than 6 months after drug eluting stent (DES) implantation

Exclusion Criteria:

  1. ISR in bare metal stents and biodegradable stents
  2. Complicated with immune diseases
  3. ISR in left main DES
  4. Suffer from renal failure requiring dialysis treatment or is undergoing dialysis treatment
  5. Severe cardiac insufficiency (LVEF <30%)
  6. Subjects with ST segment elevation myocardial infarction within 7 days of onset of chest pain
  7. Pregnant or lactating women
  8. Combined with other diseases, life expectancy <1 year
  9. Follow - up visits required by the protocol cannot be followed, or the investigators believe that the participation of subjects in the trial will increase the risk
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04518826


Contacts
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Contact: Qing Qin, MD 021-64041990 ext 5112 qin.qing@zs-hospital.sh.cn

Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Principal Investigator: Junbo Ge, MD Fudan University
More Information
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04518826    
Other Study ID Numbers: FFRCAG
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Shanghai Zhongshan Hospital:
fractional flow reserve
in stent restenosis
drug eluting stent
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases