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Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions (DCB-BIF)

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ClinicalTrials.gov Identifier: NCT04242134
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE January 20, 2020
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date July 22, 2020
Estimated Study Start Date  ICMJE August 2020
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
Rate of major adverse cardiac event [ Time Frame: 12 months after angioplasty ]
MACE defined as the composite of cardiac death, myocardial infarction (MI), and clinically driven TLR.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
  • Rate of all-cause death or cardiac death [ Time Frame: 12 months after angioplasty ]
    In general, all deaths are considered cardiac unless an alternate cause is unequivocally established, even among subjects with serious noncardiac comorbidities.
  • Rate of periprocedural MI, Spontaneous MI, or target vessel MI [ Time Frame: 12 months after angioplasty ]
    According to the DCB-BIF trial definition.
  • Rate of clinically-driven TLR or TVR [ Time Frame: 12 months after angioplasty ]
    Clinically driven revascularization includes repeat PCI or coronary artery bypass graft (CABG) for recurrent or persistent symptomatic ischemia and can be defined according to the relationship to the index PCI (target lesion).
  • Rate of thrombosis [ Time Frame: 12 months after angioplasty ]
    The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 23, 2020)
  • Rate of Angiographic success [ Time Frame: 1 day ]
    PCI is considered successful for lesions treated with stent implantation if the residual diameter stenosis based on visual estimation is less than or equal to 10% and the final TIMI flow grade is 3. PCI is considered successful for lesions treated without stent implantation if the residual diameter stenosis based on visual estimation is less than or equal to 20% and the final TIMI flow grade is 3.
  • Rate of clinical procedural success [ Time Frame: 7 day ]
    Successful PCI without MACE during hospital stay.
  • Crossover rate [ Time Frame: 1 day ]
    From single stent technique to two-stent technique
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
Official Title  ICMJE Comparison of Noncompliant Balloon With Drug-coating Balloon Angioplasties for Side Branch After Provisional Stenting for Patients With True Coronary Bifurcation Lesions
Brief Summary This study is designed to investigate whether drug-coated balloon (DCB) compared to conventional balloon angioplasty for side branch after provisional stenting will lead to lower rates of the composite endpoint of major adverse cardiac event (MACE) at 12 months. The individual components of MACE include cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). True bifurcation lesions were defined according to Medina classification.
Detailed Description

This is a prospective, multi-center, randomized-controlled, single blind, superiority trial that will include 25 international sites. The investigators aim to enroll 784 subjects with true coronary bifurcation lesions in native coronary arterial segments.

All patients with true coronary bifurcation lesions suitable for angioplasty will undergo 1:1 randomization either to PS (provisional stenting)-DCB or PS-NCB (noncompliant balloon) group using a randomization schedule blocked by site.

All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo angiography after successful stenting of the main vessel with ostium side branch visually estimated stenosis ≥70%. Data and images will be collected during the index procedure, during re-intervention in the case of clinically driven revascularization, and at the predefined 12-month clinical follow-up visit. All subjects will also undergo angiographic follow-up at 13 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients will undergo 1:1 randomization to either PS-DCB which will be the treatment group or PS-NCB which will be the control group based on an online Clinical Research Data Management Platform provided by King Yee, Beijing CN. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary endpoint are scheduled at 1, 6, and 12 months after the index procedure. Angiographic follow-up is scheduled at 13 months.
Masking: Single (Outcomes Assessor)
Masking Description:
Outcomes assessor will remain blinded until the final study results are released.
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Device: Drug-coating balloon
Provisional stenting technique with DCB
Other Name: DCB
Study Arms  ICMJE
  • Experimental: PS-DCB

    For PS-DCB group

    1. NC balloon dilating ostial side branch (SB) (1:1 ratio).
    2. DCB dilating SB. Specifically, the DCB, which had to be 2-3 mm longer on each side than the predilatation balloon, was inflated at nominal pressure for 30~ 60 s. The ratio of the DCB diameter to the nominal diameter of the SB was recommended to be between 0.8 and 1.0. DCB should be delivered to the lesion within 2 min after entering human body.
    3. Kissing inflation using 2 noncomplian balloons.
    4. Stenting side branch with T and protrusion (TAP) technique if any of the following issues was observed after kissing balloon inflation: >type C dissection or thrombolysis in myocardial infarction (TIMI) flow <3.
    5. Final kissing inflation and proximal optimal technique (POT).
    Intervention: Device: Drug-coating balloon
  • Active Comparator: PS-NCB

    For PS-NCB group

    1. NC balloon dilating ostial SB (1:1 ratio).
    2. Kissing inflation using 2 NC balloons.
    3. Stenting side branch with TAP technique if any of the following issues was observed after kissing balloon inflation: >type C dissection or thrombolysis in myocardial infarction (TIMI) flow <3.
    4. Final kissing inflation and proximal optimal technique (POT).
    Intervention: Device: Drug-coating balloon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2020)
784
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject must be age ≥18 years.
  2. Subject has silent ischemia, or stable/unstable angina, or acute MI older than 1-week from the onset of chest pain to admission.
  3. Subject (or legal guardian) understands the trial design and treatment procedures and provides written informal consent before any trial-specific tests or procedures are performed.
  4. Subject is willing to comply with all protocol-required follow-up evaluations.
  5. Target lesion must be a true bifurcation lesion on coronary angiography (defined as Medina 0,1,1, Medina 1,0,1, or Medina 1,1,1 coronary bifurcation lesions) and is eligible for percutaneous coronary intervention (PCI).
  6. Target lesion reference vessel diameter (both main vessel and side branch) ≥ 2.5 mm by visual estimation.
  7. Target lesion must have visually estimated stenosis ≥50%.
  8. Target lesion length of side branch must be <10 mm by visual estimation.
  9. Ostium side branch must have visually estimated stenosis ≥70% after stenting of the main vessel.

Exclusion Criteria:

  1. Patient with STEMI (within 1-week from the onset of chest pain to admission).
  2. Patient has known allergy to the study balloon/stent system or protocol-required concomitant medications.
  3. Patient is intolerable to dual anti-platelet therapy.
  4. Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.
  5. Patient is pregnant or nursing.
  6. Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure.
  7. Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.
  8. Restenotic lesion.
  9. Chronic total occlusion (CTO) lesion in either main vessel or side branch is not successfully recanalized.
  10. Severe calcification needing rotational atherectomy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shao-Liang Chen, MD, PhD +86-25-52208048 chmengx@126.com
Contact: Jing Kan, MPH +86-25-52271398 kanjingok@126.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04242134
Other Study ID Numbers  ICMJE NFH20191128
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University
Study Sponsor  ICMJE Nanjing First Hospital, Nanjing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Shao-Liang Chen, MD, PhD Nanjing First Hospital, Nanjing Medical University
PRS Account Nanjing First Hospital, Nanjing Medical University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP