Coronary StenosisPhase 3FADDYNCT03452904
FrActional Flow Reserve Guided Drug Coated Balloon Only Strategy in De Novo coronarY Lesions (FADDY)
A Phase 3 study testing Drug-coated balloon and Drug-eluting stent in people with Coronary Stenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis
- What is being tested?
- Drug-coated balloon and Drug-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Sep 2018
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Criteria:
- Patients with age >= 18 years old
- Patients with coronary artery disease is confirmed by angiography
- Patients with angina (CCS class II-IV) or documented ischemia evidence with ECG or ECT
- Patients agree to sign the informed consent
- Angiographic Criteria:
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- In suit coronary lesions
- Reference diameters of target vessels by visual estimation from 2.5 mm to 3.5 mm and < 28 mm in length
- Lesion diameter stenosis >= 70% by visual estimation or >= 50% with objective ischemia evidence (exercise stress testing, ECT or FFR< 0.8)
Who cannot join
- Clinical Criteria:
- Patients with STEMI <= 1 week
- Patients with LVEF < 30%
- Patients with bleeding diathesis or known anticoagulation dysfunction
- 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
- Patients with planed selective operation probably leading to stopping using ADP receptor antagonists in advance
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- Patients with life expectancy is less than 1 year because of combined comorbidity of other system
- Angiographic Criteria:
- Acute thrombotic lesions
- Left main coronary artery lesions
- Severe intima tear lesions
- Coronary artery bypass grafts lesions
- In-stent restenosis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jun Jiang, MD,PhD, +86-13588706891, drjayj@hotmail.com
Jian-an Wang, MD,PhD
About this study
Official title: 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.
- Conditions
- Coronary Stenosis
- Being tested
- Drug-coated balloon, Drug-eluting stent
- Keywords
- In suit coronary lesions, Drug-coated balloon, Drug-eluting stent, Restenosis
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-coated balloonDevice
Treatment of in suit coronary lesions with drug-coated balloon
Drug-eluting stentDevice
Treatment of in suit coronary lesions with drug-eluting balloon
| Study group | Role | What they receive |
|---|---|---|
| Drug-coated balloon | Experimental | Treatment of in suit coronary lesions with drug-coated balloon Receives: Device: Drug-coated balloon |
| Drug-eluting stent | Active comparator | Treatment of in suit coronary lesions with drug-eluting stent Receives: Device: Drug-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
9-month fractional flow reserve value
Measured: 9 months
Secondary outcomes (6)
Late lumen loss
Measured: 9 months
Percent restenosis
Measured: 9 months
Failure rate of target lesions
Measured: 9 months
Rate of thrombosis in target lesions
Measured: 9 months
Cumulative MACE rate
Measured: 9 months
Success rate of the strategy
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study startJan 2017
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo No. 1 Hospital
- Responsible party
- Sponsor
- Investigators
- Jian-an Wang, MD,PhD, Study chair, Second Affiliated Hospital of Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452904
- Sponsor's protocol ID
- SAHZJU CT008
- Acronym
- FADDY
- Status last verified
- Dec 2017
- First submitted
- 22 Feb 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen D, Yidilisi A, Zhang Y, Fang J, Zheng Y, Gao F, Li W, Zhou H, Chen Y, Lu D, Wang J, Jiang J. Fractional Flow Reserve-Guided Drug-Coated Balloon vs Drug-Eluting Stent for de Novo Non-Small Coronary Lesions. JACC Cardiovasc Interv. 2024 May 13;17(9):1182-1184. doi: 10.1016/j.jcin.2024.01.276. Epub 2024 Feb 21. No abstract available.
PubMed 38385923
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized FADDY Study (FrActional Flow Reserve Guided Drug Coated Balloon Only Strategy in De Novo coronarY Lesions)
- ClinicalTrials.gov ID
- NCT03452904
- Acronym / sponsor ID
- FADDY / SAHZJU CT008
- Conditions
- Coronary Stenosis
- Keywords
- In suit coronary lesions, Drug-coated balloon, Drug-eluting stent, Restenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Ningbo No. 1 Hospital
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 2 Mar 2018 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-coated balloon | Experimental | Device: Drug-coated balloonTreatment of in suit coronary lesions with drug-coated balloon |
| Drug-eluting stent | Active comparator | Device: Drug-eluting stentTreatment of in suit coronary lesions with drug-eluting stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical Criteria:
- Angiographic Criteria:
Key exclusion criteria (13 listed)
- Clinical Criteria:
- Angiographic Criteria:
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 |
|---|---|---|
| Drug-coated balloonTreatment of in suit coronary lesions with drug-coated balloon | Device | Drug-coated balloon |
| Drug-eluting stentTreatment of in suit coronary lesions with drug-eluting balloon | Device | Drug-eluting stent |
Primary outcome
9-month fractional flow reserve value
Time frame: 9 months
6 secondary outcomes
Late lumen loss
Time frame: 9 months
Percent restenosis
Time frame: 9 months
Failure rate of target lesions
Time frame: 9 months
Rate of thrombosis in target lesions
Time frame: 9 months
Cumulative MACE rate
Time frame: 9 months
Success rate of the strategy
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Derived from this study: PubMed 38385923Chen D, Yidilisi A, Zhang Y, Fang J, Zheng Y, Gao F, Li W, Zhou H, Chen Y, Lu D, Wang J, Jiang J. Fractional Flow Reserve-Guided Drug-Coated Balloon vs Drug-Eluting Stent for de Novo Non-Small Coronary Lesions. JACC Cardiovasc Interv. 2024 May 13;17(9):1182-1184. doi: 10.1016/j.jcin.2024.01.276. Epub 2024 Feb 21. No abstract available.
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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.
Jian-an Wang, MD,PhD study chair
Second Affiliated Hospital of Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Drug-coated balloon and Drug-eluting stent in people with Coronary Stenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 9 inclusion and 13 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 23 Mar 2018. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jun Jiang, MD,PhD (+86-13588706891, drjayj@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
9-month fractional flow reserve value (time frame: 9 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 NCT03452904, which also lists 1 linked publication.
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 23 Mar 2018.