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

NCT ID: NCT03452904

Last Updated: 2018-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-09-30

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug-coated balloon

Treatment of in suit coronary lesions with drug-coated balloon

Group Type: EXPERIMENTAL

Drug-coated balloon

Intervention Type: DEVICE

Treatment of in suit coronary lesions with drug-coated balloon

Drug-eluting stent

Treatment of in suit coronary lesions with drug-eluting stent

Group Type: ACTIVE_COMPARATOR

Drug-eluting stent

Intervention Type: DEVICE

Treatment of in suit coronary lesions with drug-eluting balloon

Interventions

Drug-coated balloon

Treatment of in suit coronary lesions with drug-coated balloon

Intervention Type: DEVICE

Drug-eluting stent

Treatment of in suit coronary lesions with drug-eluting balloon

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ningbo No. 1 Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian-an Wang, MD,PhD

Role: STUDY_CHAIR

Second Affiliated Hospital of Zhejiang University, School of Medicine

Locations

Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Jiang, MD,PhD

Role: CONTACT

drjayj@hotmail.com

+86-13588706891

Jian-an Wang, MD,PhD

Role: CONTACT

Wang_jian_an@tom.com

+86-13805786328

Facility Contacts

Jun Jiang, MD,PhD

Role: primary

drjayj@hotmail.com

+86-13588706891

Other Identifiers

SAHZJU CT008

Identifier Type: -

Identifier Source: org_study_id