Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct (BVS in STEMI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Haukeland University Hospital
Sponsor:
Collaborators:
Aarhus University Hospital Skejby
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Oslo University Hospital
St. Olavs Hospital
University Hospital of North Norway
Feiring
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT02067091
First received: February 11, 2014
Last updated: August 29, 2014
Last verified: August 2014

February 11, 2014
August 29, 2014
August 2014
August 2016   (final data collection date for primary outcome measure)
  • Coronary Stent Healing Index (cumulated) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    1. Uncovered struts: 2% =1 - 5% =2 - 10% =3 - 15% =4 - 20% =5 - 25% =6 - 30% =7 - 35% =8 - 40% =9
    2. Uncovered struts in front of side branch on acquired or persistent malposed struts. 10% =1 - 20% =2 - 30% =3 etc… til 100%=10
    3. Persistent malposition: ≥2 nabo struts længde mindst 1 mm =1 ; ≥2mm=3 ; ≥3 mm = 3
    4. Acquired malposition: ≥2 adjacent struts of at least 1 mm length =2 ; ≥2mm=4 ; ≥3 mm = 6
    5. Neointimal thickness in one frame >200 =1 - >300 =2 - >400 =3 or diameter stenosis >50% =4 - > 75% =5
    6. Cumulated extra stent lumen increase in match cross sectional analysis: (gns. areal mål): ≥0.2mm2 =1 ; ≥0.4 mm2 = 2; ≥0.6mm2=3 ; ≥0.8 mm2 = 4 ; ≥1.0 mm2=5 ; ≥1.2 mm2 = 6
  • Multislice computed tomography [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    MSCT-CA will be done at 24 months to extend the observational time by a non-invasive measure. MSCT-CA will be compared to conventional angiogram with OCT at 12 months to verify MSCT-CA findings at 24 months. Results will be reported in separate paper.
  • Multislice computed tomography [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    MSCT-CA will be done at 24 months to extend the observational time by a non-invasive measure. MSCT-CA will be compared to conventional angiogram with OCT at 12 months to verify MSCT-CA findings at 24 months.
  • Minimum flow area [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Follows definitions from the "Consensus Standards for Acquisition, Measurement, and Reporting of Intravascular Optical Coherence Tomography Studies" paper by Tearney et al. JACC 2012

    • Segments to follow definitions in coming consensus standards

      • Quantitative measurements

    • Segments to follow definitions in coming consensus standards

    Primary endpoint is Minimum flow area (MinFA). However no single OCT endpoint is fully descriptive of the healing process around coronary stent. Other data recorded will be presented as a combined endpoint. All OCT images will be kept for substudies substudies on other parameters.

Complete list of historical versions of study NCT02067091 on ClinicalTrials.gov Archive Site
  • Total Death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Total death encompasses cardiac death and other fatal categories, which include cerebrovascular death, death from other cardiovascular disease (i.e. pulmonary embolism, dissection aortic aneurysm will be included in this category), death from malignant disease, death from suicide, violence or accident, or death from other reasons.
  • Cardiac death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Cardiac death encompasses coronary heart disease death including fatal myocardial infarction, sudden cardiac death including fatal arrhythmias and cardiac arrest without successful resuscitation, death from heart failure including cardiogenic shock, and death related to a cardiac procedure or surgery within 28 days from the procedure.
  • Myocardial infarction [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    Evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Under these conditions any one of the following criteria meets the diagnosis for myocardial infarction :

    1. Detection of rise and/or fall of preferably troponin T with at least one value above the 99th percentile of the upper reference limit (URL) together with evidence of myocardial ischemia with at least one of the following (MI types 1 or 2):

      1. Symptoms of ischemia
      2. ECG changes indicative of new ischemia (new ST-T changes or new LBBB)
      3. Development of pathological Q waves in the ECG
      4. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
    2. Sudden, unexpected cardiac death, involving cardiac arrest.
  • Stent thrombosis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Stent thrombosis is recognized when documented by angiography and/or autopsy and when meeting the criteria for spontaneous myocardial infarction occurring in the territory of the treated vessel (11). Stent thrombosis are categorized as acute, sub-acute, late and very late and as definite, probable and possible according to the ARC-criteria (12).
  • Target Lesion and vessel Revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Coronary artery bypass grafting with grafting or PCI of index lesion. Coronary artery bypass grafting with grafting or PCI of index vessel.
  • Non Target vessel revascularisation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    All PCI or coronary bypass grafting of non index vessel
  • Stable angina [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Angina as reported by patient, classified according to Canadian cardiac society class (CCS)
  • Vascular cerebral events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Vascular events documented by neurological permanent disabilities or by diagnostic imaging (MRI or CT).
  • Admission for congestive heart failure or arrhythmias [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Admissions were the diagnosis at release is one of heart failure or arrhythmias
  • Optical Coherence tomography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Area stenosis
  • Angiographic endpoints at index admission [ Time Frame: After index procedure were the patient is included and randomized ] [ Designated as safety issue: Yes ]
    TIMI flow pre and post PCI
  • Biochemical [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Creatinine, hemoglobin, Troponin T will be analyzed during index procedure post procedure and at 12 months follow-up. ProBNP will be analyzed at 12 months follow-up
  • Markers [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Plasma, full blood, serum and urine will be drawn immediately after the procedure and frozen in a bio bank for later analysis
  • Thrombus analysis [ Time Frame: At index procedure were the patient is included and randomized ] [ Designated as safety issue: No ]
    Visible thrombus aspirates will be sent for analysis
  • Optical coherence tomography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Lumen late loss
  • Optical coherence tomography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Crushed stent segments
  • Optical coherence tomography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Malposition of stent segments
  • Optical coherence tomography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Minimum expansion of stent struts expressed as absolute area and percentage of closest reference reference area
  • Optical coherence tomography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Vessel ostial stented area (acute and at FU)
  • Optical coherence tomography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Thrombus burden
  • Angiographic endpoints at index admission [ Time Frame: After index procedure were the patient is included and randomized ] [ Designated as safety issue: Yes ]
    Blush grade
  • Angiographic endpoints at index admission [ Time Frame: After index procedure were the patient is included and randomized ] [ Designated as safety issue: Yes ]
    Thrombus burden
  • Angiographic endpoints at index admission [ Time Frame: After index procedure were the patient is included and randomized ] [ Designated as safety issue: Yes ]
    Angiographic complications
  • Angiographic endpoints at index admission [ Time Frame: After index procedure were the patient is included and randomized ] [ Designated as safety issue: Yes ]
    Contrast use
  • Angiographic endpoints at index admission [ Time Frame: After index procedure were the patient is included and randomized ] [ Designated as safety issue: Yes ]
    Procedure time
  • Angiographic endpoints at index admission [ Time Frame: After index procedure were the patient is included and randomized ] [ Designated as safety issue: Yes ]
    Radiation skin dose
  • Optical coherence tomography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Minimum flow area
  • Total Death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Total death encompasses cardiac death and other fatal categories, which include cerebrovascular death, death from other cardiovascular disease (i.e. pulmonary embolism, dissection aortic aneurysm will be included in this category), death from malignant disease, death from suicide, violence or accident, or death from other reasons.
  • Cardiac death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Cardiac death encompasses coronary heart disease death including fatal myocardial infarction, sudden cardiac death including fatal arrhythmias and cardiac arrest without successful resuscitation, death from heart failure including cardiogenic shock, and death related to a cardiac procedure or surgery within 28 days from the procedure.
  • Myocardial infarction [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    Evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Under these conditions any one of the following criteria meets the diagnosis for myocardial infarction :

    1. Detection of rise and/or fall of preferably troponin T with at least one value above the 99th percentile of the upper reference limit (URL) together with evidence of myocardial ischemia with at least one of the following (MI types 1 or 2):

      1. Symptoms of ischemia
      2. ECG changes indicative of new ischemia (new ST-T changes or new LBBB)
      3. Development of pathological Q waves in the ECG
      4. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
    2. Sudden, unexpected cardiac death, involving cardiac arrest.
  • Stent thrombosis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Stent thrombosis is recognized when documented by angiography and/or autopsy and when meeting the criteria for spontaneous myocardial infarction occurring in the territory of the treated vessel (11). Stent thrombosis are categorized as acute, sub-acute, late and very late and as definite, probable and possible according to the ARC-criteria (12).
  • Target Lesion and vessel Revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Coronary artery bypass grafting with grafting or PCI of index lesion. Coronary artery bypass grafting with grafting or PCI of index vessel.
  • Non Target vessel revascularisation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    All PCI or coronary bypassgrafting of non index vessel
  • Stable angina [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Angina as reported by patient, classified according to canadian cardiac society class (CCS)
  • Vascular cerebral events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Vascular events documented by neurological permanent disabilities or by diagnostic imaging (MRI or CT).
  • Admission for congestive heartfailure or arrythmias [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Admissions were the diagnosis at release is one of heart failure or arrythmia
  • Optical Coherence tomography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Area stenosis
  • Angiographic endpoints at index admission [ Time Frame: index ] [ Designated as safety issue: Yes ]
    TIMI flow pre and post PCI,
  • Biochemical [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Creatinin, hemoglobin, Troponin T will be analyzed during index procedure post procedure and at 12 months follow up. ProBNP will be analyzed at 12 months follow-up
  • Markers [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Plasma, full blood, serum and urin will be drawn immediately after the procedure and frozen in a bio bank for later analysis
  • Thrombus analysis [ Time Frame: index ] [ Designated as safety issue: No ]
    Visible thrombus aspirates will be sent for analysis
  • Optical coherence tomography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Lumen late loss
  • Optical coherence tomography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Crushed stent segments
  • Optical coherence tomography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Malapposition of stent segments
  • Optical coherence tomograhpy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Minimum expansion of stent struts expressed as absolute area and percentage of closest reference reference area
  • Optical coherence tomography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Vessel ostial stented area (acute and at FU)
  • Optical coherence tomography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Thrombus burden
  • Angiographic endpoints at index admission [ Time Frame: index ] [ Designated as safety issue: Yes ]
    Blush grade
  • Angiographid endpoints at index admission [ Time Frame: index ] [ Designated as safety issue: Yes ]
    Thrombus burden
  • Angiograpphic endpoints at index admission [ Time Frame: index ] [ Designated as safety issue: Yes ]
    Angiographic complications
  • Angiographic endpoints at index admission [ Time Frame: index ] [ Designated as safety issue: Yes ]
    Contrast use
  • Angiographic endpoints at index admission [ Time Frame: index ] [ Designated as safety issue: Yes ]
    Procedure time
  • Angiographic endpoints at index admission [ Time Frame: index ] [ Designated as safety issue: Yes ]
    Radiation skin dose
Not Provided
Not Provided
 
Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct
Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct (BVS in STEMI)

Patients presenting with acute ST elevation myocardial infarct urgently need revascularization. Standard of care is establishing bloodflow through the coronary vessels using thrombus aspiration catheter, and securing the result by using a metallic drug eluting stent. New kinds of non-metallic bioresorbable stents are now available. They have however challenges in structural strength.

The investigators want to compare the new bioresorbable scaffold with traditional metallic stents in this setting in a prospective, randomized, non-blinded, multicenter study in 120 patients. The investigators will use an imaging technique, optical coherence tomography, to evaluate the results after 12 months.

The investigators also want to see if modern multislice computed tomography can give useful information in the follow-up of stented coronary arteries after 12 and 24 months.

Patients presenting with ST elevation myocardial infarction for primary PCI (percutaneous coronary intervention) will be screened. After thrombus aspiration, patient will be asked for oral consent if TIMI flow 2-3. Patient will then be randomized between drug eluting stent (Xience pro, Abbott Vascular Solutions) and bioresorbable scaffold (Absorb, Abbott Vascular Solutions). Optical coherence tomography (OCT) will be performed before stenting and after final result. Stent will be deployed without further predilatation if possible. Follow up at 12 months (clinical, angio with OCT and multislice CT coronary angiogram (MSCT-CA)) and 24 months (MSCT-CA).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute ST Segment Elevation Myocardial Infarction
Device: stent implant in a coronary artery

Implantation of device called a stent in a coronary artery

Percutaneous coronary intervention

  • Active Comparator: BVS
    Implantation of bioresorbable vascular scaffold in coronary artery by direct stenting after thrombus aspiration by percutaneous coronary intervention
    Intervention: Device: stent implant in a coronary artery
  • Active Comparator: DES
    Implantation of drug eluting stent in coronary artery by direct stenting after thrombus aspiration by percutaneous coronary intervention
    Intervention: Device: stent implant in a coronary artery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
August 2020
August 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. History of chest pain < 12 hrs
  2. ST elevation of ≥ 2 mm in ≥2 contiguous precordial leads (V1-V6), and/or ≥ 1 mm in ≥ 2 contiguous standard leads (I, II, III, aVf, aVr,aVl).
  3. Clinical decision to treat with primary PCI
  4. > 18 years
  5. Oral informed consent

Exclusion Criteria:

  1. Contraindications to long term double antiplatelet therapy
  2. Known kidney failure with GFR < 45
  3. Cardiac arrest or severe cardiogenic shock (Persistent BP <90 mmHg, despite adequate treatment)
  4. Other severe illness with life expectancy of less than 12 months (eg. malignancy, severe malnutrition, degenerative disease)

Procedural contraindications:

  1. Heavy calcification, tortuous vessel or large side branch (> 2,5 mm) at culprit lesion.
  2. TIMI 0-1 flow after aspiration
  3. Unable to advance thrombus aspiration catheter
Both
18 Years and older
No
Contact: Erlend Eriksen, MD +4755972220 ext 6733 eeer@helse-bergen.no
Contact: Jon Herstad, MD +4755972220 ext 2191 jon.herstad@helse-bergen.no
Denmark,   Norway
 
NCT02067091
2013/2006
Yes
Haukeland University Hospital
Haukeland University Hospital
  • Aarhus University Hospital Skejby
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Oslo University Hospital
  • St. Olavs Hospital
  • University Hospital of North Norway
  • Feiring
Study Chair: Vegard Tuseth, PhD University of Bergen
Study Chair: Jan Erik Nordrehaug, PhD University of Bergen
Principal Investigator: Erlend Eriksen, MD Helse-Bergen HF
Haukeland University Hospital
August 2014

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