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出境医 / 临床实验 / OCT Guided Magmaris RMS in STEMI (BESTMAG)

OCT Guided Magmaris RMS in STEMI (BESTMAG)

Study Description
Brief Summary:
Percutaneous treatment of coronary artery disease depends on the implantation of stents within diseased coronary segments. Compared with conventional bare-metal and drug- eluting stents, which remain permanently within the coronary anatomy, bioresorbable scaffolds (BRS) offer several potential advantages due to its resorbable properties. The resorbable magnesium scaffold Magmaris has demonstrated favourable outcomes in patients with stable coronary artery disease. In particular, in comparison to polymeric bioresorbable scaffolds, no cases of stent thrombosis have been reported in over two years of follow-up suggesting that magnesium-based resorbable scaffolds have low thrombogenicity and might be particularly beneficial for patients presenting with ST- segment myocardial infarction. A recent pilot study in eighteen patients supports this concept, which has led to the development of the proposed prospective multicentre study including intra-coronary imaging with long-term clinical follow-up.

Condition or disease Intervention/treatment Phase
STEMI Device: Magmaris resorbable magnesium scaffold Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optical Coherence Guided Treatment of ST-segment Elevation Myocardial Infarction With the Drug-eluting Resorbable Magnesium Scaffold: the BEST- MAG Multicentre Study. (BElgian ST-segment Elevation Myocardial Infarction Treatment With Resorbable MAGnesium Scaffold).
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : February 15, 2022
Arms and Interventions
Arm Intervention/treatment
Single study arm
STEMI Patients treated with Magmaris resorbable magnesium scaffold
 Device: Magmaris resorbable magnesium scaffold
Implantation of Magmaris resorbable magnesium scaffold
Outcome Measures
Primary Outcome Measures :
  1. A device oriented composite endpoint (DOCE) including cardiac death, target vessel myocardial infarction (attributable to the culprit lesion) and ischemic-driven target lesion revascularization (TLR) within 12 months after the index procedure. [ Time Frame: 1 year ]
    DOCE at 12 months


Secondary Outcome Measures :
  1. Procedural success defined as the delivery and deployment of RMS at the intended target lesion with a final residual stenosis ≤20% by visual estimation. [ Time Frame: in-hospital ]
    Procedure succes

  2. DOCE at 1-,6- and 24-months follow-up periods. [ Time Frame: 2 years ]
    DOCE at 1,6 and 24 months

  3. Definite or probable scaffold thrombosis. [ Time Frame: 2 years ]
    incidence scaffold thrombosis

  4. Vessel healing assessment through an angiographic with OCT follow- up procedure at 15 months in predetermined participating centres [ Time Frame: 15 months ]
    Healing characteristics on OCT evaluation

  5. All-cause death, cardiac death, non-TVR, any revascularization at 1, 6, 12 and 24 months. [ Time Frame: 2 years ]
    MACE


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptoms onset <24 hours or with ongoing symptoms.
  2. Signed patient informed consent.

Exclusion Criteria:

  1. Age < 18 or > 70 years.
  2. Pregnancy or breastfeeding.
  3. Cardiogenic shock.
  4. Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis. Note: chronic dialysis dependent patients are eligible for enrolment regardless of creatinine clearance.
  5. Infarct-artery reference diameter < 2.7 or > 4.0 mm (within the segment of the culprit lesion) by visual estimation, and OCT infarct-artery distal reference mean lumen diameter < 2.7 or > 3.7 mm
  6. Non-optimal vessel preparation after predilatation: residual stenosis >30%.
  7. Culprit lesion length > 21 mm.
  8. Culprit lesion located within a previously stented segment (stent thrombosis or in-stent restenosis).
  9. Culprit lesion involving a saphenous vein graft.
  10. Culprit lesion involving a bifurcation with an intended two-stent implantation strategy.
  11. Ostial right coronary artery
  12. Severe calcification or tortuosity of the infarct-related artery.
  13. Absolute contraindication to a 12 months dual antiplatelet therapy.
  14. Life expectancy < 3 years.
  15. Patients taking oral anticoagulant therapy
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Johan Bennett, Dr. +3216342465 johan.bennett@uzleuven.be

Locations
Layout table for location information
Belgium
Johan Bennett Recruiting
Leuven, Brabant, Belgium, 3001
Contact: Johan Bennett    479293854 ext 479293854    johan.bennett@uzleuven.be   
Sub-Investigator: Keir McCutcheon         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Centre Hospitalier Universitaire Saint Pierre
Universitair Ziekenhuis Brussel
CHU de Charleroi
Jolimont
Ziekenhuis Oost-Limburg
University Hospital St Luc, Brussels
Centre Hospitalier Universitaire Dinant Godinne - UCL Namur
Le centre hospitalier EpiCURA
Centre Hospitalier Régional de la Citadelle
Tracking Information
First Submitted Date  ICMJE February 11, 2019
First Posted Date  ICMJE May 20, 2019
Last Update Posted Date May 20, 2019
Actual Study Start Date  ICMJE February 15, 2019
Estimated Primary Completion Date February 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019) 		A device oriented composite endpoint (DOCE) including cardiac death, target vessel myocardial infarction (attributable to the culprit lesion) and ischemic-driven target lesion revascularization (TLR) within 12 months after the index procedure. [ Time Frame: 1 year ]
DOCE at 12 months
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • Procedural success defined as the delivery and deployment of RMS at the intended target lesion with a final residual stenosis ≤20% by visual estimation. [ Time Frame: in-hospital ]
    Procedure succes
  • DOCE at 1-,6- and 24-months follow-up periods. [ Time Frame: 2 years ]
    DOCE at 1,6 and 24 months
  • Definite or probable scaffold thrombosis. [ Time Frame: 2 years ]
    incidence scaffold thrombosis
  • Vessel healing assessment through an angiographic with OCT follow- up procedure at 15 months in predetermined participating centres [ Time Frame: 15 months ]
    Healing characteristics on OCT evaluation
  • All-cause death, cardiac death, non-TVR, any revascularization at 1, 6, 12 and 24 months. [ Time Frame: 2 years ]
    MACE
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 OCT Guided Magmaris RMS in STEMI
Official Title  ICMJE Optical Coherence Guided Treatment of ST-segment Elevation Myocardial Infarction With the Drug-eluting Resorbable Magnesium Scaffold: the BEST- MAG Multicentre Study. (BElgian ST-segment Elevation Myocardial Infarction Treatment With Resorbable MAGnesium Scaffold).
Brief Summary Percutaneous treatment of coronary artery disease depends on the implantation of stents within diseased coronary segments. Compared with conventional bare-metal and drug- eluting stents, which remain permanently within the coronary anatomy, bioresorbable scaffolds (BRS) offer several potential advantages due to its resorbable properties. The resorbable magnesium scaffold Magmaris has demonstrated favourable outcomes in patients with stable coronary artery disease. In particular, in comparison to polymeric bioresorbable scaffolds, no cases of stent thrombosis have been reported in over two years of follow-up suggesting that magnesium-based resorbable scaffolds have low thrombogenicity and might be particularly beneficial for patients presenting with ST- segment myocardial infarction. A recent pilot study in eighteen patients supports this concept, which has led to the development of the proposed prospective multicentre study including intra-coronary imaging with long-term clinical follow-up.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE STEMI
Intervention  ICMJE Device: Magmaris resorbable magnesium scaffold
Implantation of Magmaris resorbable magnesium scaffold
Study Arms  ICMJE Single study arm
STEMI Patients treated with Magmaris resorbable magnesium scaffold
Intervention: Device: Magmaris resorbable magnesium scaffold
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 15, 2022
Estimated Primary Completion Date February 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptoms onset <24 hours or with ongoing symptoms.
  2. Signed patient informed consent.

Exclusion Criteria:

  1. Age < 18 or > 70 years.
  2. Pregnancy or breastfeeding.
  3. Cardiogenic shock.
  4. Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis. Note: chronic dialysis dependent patients are eligible for enrolment regardless of creatinine clearance.
  5. Infarct-artery reference diameter < 2.7 or > 4.0 mm (within the segment of the culprit lesion) by visual estimation, and OCT infarct-artery distal reference mean lumen diameter < 2.7 or > 3.7 mm
  6. Non-optimal vessel preparation after predilatation: residual stenosis >30%.
  7. Culprit lesion length > 21 mm.
  8. Culprit lesion located within a previously stented segment (stent thrombosis or in-stent restenosis).
  9. Culprit lesion involving a saphenous vein graft.
  10. Culprit lesion involving a bifurcation with an intended two-stent implantation strategy.
  11. Ostial right coronary artery
  12. Severe calcification or tortuosity of the infarct-related artery.
  13. Absolute contraindication to a 12 months dual antiplatelet therapy.
  14. Life expectancy < 3 years.
  15. Patients taking oral anticoagulant therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Johan Bennett, Dr. +3216342465 johan.bennett@uzleuven.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03955731
Other Study ID Numbers  ICMJE 62036
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Universitaire Ziekenhuizen Leuven
Study Sponsor  ICMJE Universitaire Ziekenhuizen Leuven
Collaborators  ICMJE
  • Centre Hospitalier Universitaire Saint Pierre
  • Universitair Ziekenhuis Brussel
  • CHU de Charleroi
  • Jolimont
  • Ziekenhuis Oost-Limburg
  • University Hospital St Luc, Brussels
  • Centre Hospitalier Universitaire Dinant Godinne - UCL Namur
  • Le centre hospitalier EpiCURA
  • Centre Hospitalier Régional de la Citadelle
Investigators  ICMJE Not Provided
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date January 2019

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

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