Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy

NCT ID: NCT04842838

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2025-06-30

Brief Summary

The trial aims to evaluate the long-term clinical outcome of the DCB-only technique is non-inferior to the provisional T stenting with DES in the patients who have 'true' bifurcation lesions.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DCB strategy

Group Type: EXPERIMENTAL

paclitaxel DCB

Intervention Type: DEVICE

Drug-coated balloon is a new kind of coronary interventional device. The balloon coated with anti-cell proliferation drugs (paclitaxel, etc.) is sent to the stenosis site. The balloon is closely adhered to the vascular wall during the expansion, and the drug is rapidly and evenly coated on the disaffected vessels.In recent years, DCB has gradually become an alternative for the treatment of in-stent restenosis (ISR), small vessel disease (SVD) and bifurcation disease.

DES strategy

Group Type: ACTIVE_COMPARATOR

DES

Intervention Type: DEVICE

Provisional T technique is the preferred method for the treatment of bifurcation lesions with the existing stent.According to the 2018 European Guidelines on revascularization and the consensus group of the European Bifurcation Club (EBC), Provisional T technique is still the first choice for the treatment of Bifurcation, despite the problems related to side branches.

Interventions

paclitaxel DCB

Drug-coated balloon is a new kind of coronary interventional device. The balloon coated with anti-cell proliferation drugs (paclitaxel, etc.) is sent to the stenosis site. The balloon is closely adhered to the vascular wall during the expansion, and the drug is rapidly and evenly coated on the disaffected vessels.In recent years, DCB has gradually become an alternative for the treatment of in-stent restenosis (ISR), small vessel disease (SVD) and bifurcation disease.

Intervention Type: DEVICE

DES

Provisional T technique is the preferred method for the treatment of bifurcation lesions with the existing stent.According to the 2018 European Guidelines on revascularization and the consensus group of the European Bifurcation Club (EBC), Provisional T technique is still the first choice for the treatment of Bifurcation, despite the problems related to side branches.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. At least 18 years old;

2. Evidence of myocardial ischemia and indications of PCI, stable or unstable angina pectoris, or old myocardial infarction;

3. Primary and bifurcated coronary artery lesions (Medina classification 1,1,1 or 1,0,1 or 0,1,1);

4. Visual angiography of the main branch reference vessel diameter ≥2.5mm, and ≤4.0mm;Branch reference vessel diameter ≥2.0mm;

5. Diameter stenosis of main and branch lesions ≥ 70%, and diameter stenosis of branch lesions ≥ 50%;

6. Visual examination of residual stenosis of main branch lesions after pre-dilation ≤ 30% without vascular dissection or dissection with NHLBI classification A, B, C type.

7. If 2 bifurcation lesions meet the inclusion requirements, only 1 lesion can be included in the study, and the other lesion can be treated or not treated as a non-target lesion.

Exclusion Criteria

1. Main branch or branching target lesions require treatment with more than one device (DES or DCB);

2. There is more than 1 non-target lesion requiring intervention on the target blood vessel;

3. The distance between non-target lesion and target lesion is less than 10 mm;

4. Main and branch lesions > 26 mm or branch lesions length BBB> mm;

5. Left main lesion and its bifurcation lesion;

6. Intra-stent restenosis or severe calcification;

7. ST-segment elevation or non-ST-segment elevation myocardial infarction 7 days before surgery;

8. Severe heart failure (NYHA-IV or left ventricular ejection fraction <35%);

9. Cardiogenic shock;

10. known to have renal failure (EGFR <30ml/min/1.73m2);

11. Pregnant or lactating women, or women of reproductive age who had family planning or were unable to take adequate contraceptive measures during the study period;

12. Any known allergic reactions or contraindications to the drug and coating or scaffold metal required for DCB in the study;

13. Other DES or DCB treatment contraindications;

14. Failing to sign an informed consent or having an expected life of less than 12 months;

15. Other researchers consider it inappropriate to participate in this study.

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

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Yida Tang, Prof

Role: CONTACT

tang_yida@163.com

13901010211

Yupeng Wang, Prof

Role: CONTACT

wangyp007@163.com

Facility Contacts

Yida Tang, Prof

Role: primary

tang_yida@163.com

Yupeng Wang, Prof

Role: backup

wangyp007@163.com

Other Identifiers

CAW-PMS-R01-01

Identifier Type: -

Identifier Source: org_study_id