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

Zhejiang University

Status and phase: Unknown; Phase 3

Conditions: Coronary Stenosis

Treatments: Device: Drug-eluting stent; Device: Drug-coated balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT03452904

SAHZJU CT008

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Drug-coated balloon

Experimental group

Description:

Treatment of in suit coronary lesions with drug-coated balloon

Treatment:

Device: Drug-coated balloon

Drug-eluting stent

Active Comparator group

Description:

Treatment of in suit coronary lesions with drug-eluting stent

Treatment:

Device: Drug-eluting stent