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

NCT04842838 | Unknown

• 1 other identifier: CAW-PMS-R01-01
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Target lesion failure (TLF)

  Target lesion failure, defined as cardiac death, clinically driven target vessel myocardial infarction and target lesion revascularization.

  12 months

• Number of Participants with net adverse clinical cardiovascular events (NACCE)

  Net adverse clinical cardiovascular events, defined as cardiac death, clinically driven target vessel myocardial infarction, target lesion revascularization and major bleeding (BARC type 2, 3, 5 bleeding)

  12 months

Secondary Outcomes (8)

• Technical success rate

  1-2 days

• Number of Participants with Target lesion failure (TLF)

  1/6/24/36 month

• Number of Participants with Target lesion revascularization (TLR)

  1/6/12/24/36 month

• Number of Participants with Target vessel revascularization (TVR)

  1/6/12/24/36 month

• Clinical procedure time

  during the procedure

Study Arms (2)

DCB strategy

EXPERIMENTAL

Device: paclitaxel DCB

DES strategy

ACTIVE COMPARATOR

Device: DES

Interventions

paclitaxel DCB 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.

DCB strategy

DES 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.

DES strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old;
• Evidence of myocardial ischemia and indications of PCI, stable or unstable angina pectoris, or old myocardial infarction;
• Primary and bifurcated coronary artery lesions (Medina classification 1,1,1 or 1,0,1 or 0,1,1);
• Visual angiography of the main branch reference vessel diameter ≥2.5mm, and ≤4.0mm;Branch reference vessel diameter ≥2.0mm;
• Diameter stenosis of main and branch lesions ≥ 70%, and diameter stenosis of branch lesions ≥ 50%;
• 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.

You may not qualify if:

• Main branch or branching target lesions require treatment with more than one device (DES or DCB);
• There is more than 1 non-target lesion requiring intervention on the target blood vessel;
• The distance between non-target lesion and target lesion is less than 10 mm;
• Main and branch lesions \> 26 mm or branch lesions length BBB\> mm;
• Left main lesion and its bifurcation lesion;
• Intra-stent restenosis or severe calcification;
• ST-segment elevation or non-ST-segment elevation myocardial infarction 7 days before surgery;
• Severe heart failure (NYHA-IV or left ventricular ejection fraction \<35%);
• Cardiogenic shock;
• known to have renal failure (EGFR \<30ml/min/1.73m2);
• 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;
• Any known allergic reactions or contraindications to the drug and coating or scaffold metal required for DCB in the study;
• Other DES or DCB treatment contraindications;
• Failing to sign an informed consent or having an expected life of less than 12 months;
• Other researchers consider it inappropriate to participate in this study.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Yida Tang, Prof

CONTACT

13901010211; tang_yida@163.com

Yupeng Wang, Prof

CONTACT

wangyp007@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 13, 2021
• Study Start: June 30, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2025
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

CN (1)