In Stent RestenosisNCT04518826
A Comparison Between FFR Guided and CAG Guided Treatment Using DEB in ISR of DES
An observational study of In Stent Restenosis and Drug Eluting Stent, run by Shanghai Zhongshan Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- In Stent Restenosis, Drug Eluting Stent, Coronary Artery Disease
- What is being tested?
- fractional flow reserve
- Type of treatment
- Medical device
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Oct 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with coronary artery disease and DES implantation.
Who may be able to join
- In-stent restenosis(ISR) occurred more than 6 months after drug eluting stent (DES) implantation
Who cannot join
- ISR in bare metal stents and biodegradable stents
- Complicated with immune diseases
- ISR in left main DES
- Suffer from renal failure requiring dialysis treatment or is undergoing dialysis treatment
- Severe cardiac insufficiency (LVEF <30%)
- Subjects with ST segment elevation myocardial infarction within 7 days of onset of chest pain
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- Pregnant or lactating women
- Combined with other diseases, life expectancy <1 year
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Being tested
- fractional flow reserve
- Keywords
- fractional flow reserve, in stent restenosis, drug eluting stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractional flow reserveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: fractional flow reserve | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
target vessel failure
cardiac death, target vessel myocardial infarction, target vessel failure
Measured: 12 month
Secondary outcomes (2)
angiographic outcomes
diameter stenosis, binary stenosis and late lumen loss measured by QCA
Measured: 12 month
target vessel failure
cardiac death, target vessel myocardial infarction, target vessel failure
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Stent RestenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518826
- Sponsor's protocol ID
- FFRCAG
- Status last verified
- Aug 2020
- First submitted
- 15 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04518826
- Acronym / sponsor ID
- FFRCAG
- Keywords
- fractional flow reserve, in stent restenosis, drug eluting stent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FFR | – | Device: fractional flow reserveIn 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with coronary artery disease and DES implantation.
Key inclusion criteria (1 listed)
- In-stent restenosis(ISR) occurred more than 6 months after drug eluting stent (DES) implantation
Key exclusion criteria (9 listed)
- ISR in bare metal stents and biodegradable stents
- Complicated with immune diseases
- ISR in left main DES
- Suffer from renal failure requiring dialysis treatment or is undergoing dialysis treatment
- Severe cardiac insufficiency (LVEF <30%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fractional flow reserveFFR 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. | Device | FFR |
Primary outcome
target vessel failure
Time frame: 12 month
cardiac death, target vessel myocardial infarction, target vessel failure
2 secondary outcomes
angiographic outcomes
Time frame: 12 month
target vessel failure
Time frame: 36 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junbo Ge, MD principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
An observational study of In Stent Restenosis and Drug Eluting Stent, run by Shanghai Zhongshan Hospital.
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 1 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: status not confirmed, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing Qin, MD (021-64041990 ext. 5112, qin.qing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
target vessel failure (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2020.