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出境医 / 临床实验 / Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia (SCBDNMAL)

Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia (SCBDNMAL)

Study Description
Brief Summary:
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: PCB PTCA Device: SCB PTCA Phase 2 Phase 3

Detailed Description:
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon. Prospective, multicenter, randomized, single-blind, 70 patients. Experimental intervention: Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²). Control intervention: Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²). Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months. clinical follow up.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : October 1, 2021
Arms and Interventions
Arm Intervention/treatment
Active Comparator: PTCA of coronary de novo lesion PCB
Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²)
 Device: PCB PTCA
Predilatation of coronary de-novo stenosis followed by a PCB
Experimental: PTCA of coronary de novo lesion SCB
Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²)
 Device: SCB PTCA
Predilatation of coronary de-novo stenosis followed by a SCB
Outcome Measures
Primary Outcome Measures :
  1. late lumen loss in-segment [ Time Frame: 6 months ]
    angiographic minimal lumen diameter in-segment at 6 months minus minimal lumen diameter at baseline


Secondary Outcome Measures :
  1. Procedural success [ Time Frame: 5 days ]
    combined endpoint of: < 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE

  2. MACE [ Time Frame: at 6 and at 12 months ]
    combined endpoint of: cardiac death, target vessel myocardial infarction, and TLR target lesion revascularization in-hospital at 6 and at 12 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical evidence of stable or unstable angina or a positive functional study
  • Patients with significant coronary de-novo stenosis (≥ 70% diameter stenosis or intermediate ≥ 50% to <70% diameter stenosis with positive functional test or symptom of ischemia)
  • Successful lesion preparation (no flow-limiting dissection or a residual stenosis > 30%)

Exclusion Criteria:

  • Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI)
  • Intolerance and / or allergy to Sirolimus
  • Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient:

iopromide)

  • Patients with an ejection fraction of < 30 %
  • Reference vessel diameter (RVD) < 2.5 mm
  • Contraindication for whichever necessary accompanying medication
Contacts and Locations

Locations
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Malaysia
Sabah Heart Centre, Queen Elizabeth Hospital II Recruiting
Kota Kinabalu, Malaysia, 88300
Contact: Liew Houng Bang, MD    +6019-8172269    hbliew22@gmail.com   
Sarawak Heart Centre Recruiting
Kota Samarahan, Malaysia, 94300
Contact: Ong Tiong Kiam, MD    +60198875348    ongtk@moh.gov.my   
National Heart Institute Recruiting
Kuala Lumpur, Malaysia, 50400
Contact: Amin Ariff Nuruddin, MD    +6 012 - 320 8658    dramin@ijn.com.my   
Principal Investigator: Amin Ariff Nuruddin, MD         
Cardio Vascular Sentral Recruiting
Kuala Lumpur, Malaysia, 50470
Contact: Rosli Mohd Ali, MD    + 603 2276 7096    rosliali@cvskl.com   
University Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia, 50603
Contact: Wan Azman, MD    +6 03 - 79492429    wanazman@ummc.edu.my   
Hospital Pulau Pinang Recruiting
Penang, Malaysia, 10990
Contact: Muhamad Ali Sk Abdul Kader, MD    +60 13 4355 601    mdali_sheikh@hotmail.com   
Sponsors and Collaborators
University Hospital, Saarland
Tracking Information
First Submitted Date  ICMJE July 3, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019) 		late lumen loss in-segment [ Time Frame: 6 months ]
angiographic minimal lumen diameter in-segment at 6 months minus minimal lumen diameter at baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • Procedural success [ Time Frame: 5 days ]
    combined endpoint of: < 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE
  • MACE [ Time Frame: at 6 and at 12 months ]
    combined endpoint of: cardiac death, target vessel myocardial infarction, and TLR target lesion revascularization in-hospital at 6 and at 12 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia
Official Title  ICMJE Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter
Brief Summary To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon
Detailed Description To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon. Prospective, multicenter, randomized, single-blind, 70 patients. Experimental intervention: Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²). Control intervention: Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²). Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months. clinical follow up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Device: PCB PTCA
    Predilatation of coronary de-novo stenosis followed by a PCB
  • Device: SCB PTCA
    Predilatation of coronary de-novo stenosis followed by a SCB
Study Arms  ICMJE
  • Active Comparator: PTCA of coronary de novo lesion PCB
    Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²)
    Intervention: Device: PCB PTCA
  • Experimental: PTCA of coronary de novo lesion SCB
    Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²)
    Intervention: Device: SCB PTCA
Publications * Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040.

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2019) 		70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical evidence of stable or unstable angina or a positive functional study
  • Patients with significant coronary de-novo stenosis (≥ 70% diameter stenosis or intermediate ≥ 50% to <70% diameter stenosis with positive functional test or symptom of ischemia)
  • Successful lesion preparation (no flow-limiting dissection or a residual stenosis > 30%)

Exclusion Criteria:

  • Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI)
  • Intolerance and / or allergy to Sirolimus
  • Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient:

iopromide)

  • Patients with an ejection fraction of < 30 %
  • Reference vessel diameter (RVD) < 2.5 mm
  • Contraindication for whichever necessary accompanying medication
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04017364
Other Study ID Numbers  ICMJE SI-DN-MALAYSIA
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 University Hospital, Saarland
Study Sponsor  ICMJE University Hospital, Saarland
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Saarland
Verification Date November 2020

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

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