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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03452904
Other study ID # SAHZJU CT008
Secondary ID
Status Recruiting
Phase Phase 3
First received February 22, 2018
Last updated March 21, 2018
Start date January 2017
Est. completion date September 2018

Study information

Verified date December 2017
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Jun Jiang, MD,PhD
Phone +86-13588706891
Email drjayj@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date September 2018
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Drug-coated balloon
Treatment of in suit coronary lesions with drug-coated balloon
Drug-eluting stent
Treatment of in suit coronary lesions with drug-eluting balloon

Locations

Country Name City State
China Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang

Sponsors (2)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 9-month fractional flow reserve value 9 months
Secondary Late lumen loss 9 months
Secondary Percent restenosis 9 months
Secondary Failure rate of target lesions 9 months
Secondary Rate of thrombosis in target lesions 9 months
Secondary Cumulative MACE rate 9 months
Secondary Success rate of the strategy 9 months
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