search
Back to results

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

Primary Purpose

Acute ST Segment Elevation Myocardial Infarction

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
stent implant in a coronary artery
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute ST Segment Elevation Myocardial Infarction focused on measuring STEMI, Coronary, Bioresorbable scaffold, Drug eluting stent, Optical coherence tomography, Multislice computed tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital, Skejby
  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

BVS

DES

Arm Description

Implantation of bioresorbable vascular scaffold in coronary artery by direct stenting after thrombus aspiration by percutaneous coronary intervention

Implantation of drug eluting stent in coronary artery by direct stenting after thrombus aspiration by percutaneous coronary intervention

Outcomes

Primary Outcome Measures

Coronary Stent Healing Index (cumulated)
Uncovered struts: 2% =1 - 5% =2 - 10% =3 - 15% =4 - 20% =5 - 25% =6 - 30% =7 - 35% =8 - 40% =9 Uncovered struts in front of side branch on acquired or persistent malposed struts. 10% =1 - 20% =2 - 30% =3 etc… til 100%=10 Persistent malposition: ≥2 nabo struts længde mindst 1 mm =1 ; ≥2mm=3 ; ≥3 mm = 3 Acquired malposition: ≥2 adjacent struts of at least 1 mm length =2 ; ≥2mm=4 ; ≥3 mm = 6 Neointimal thickness in one frame >200 =1 - >300 =2 - >400 =3 or diameter stenosis >50% =4 - > 75% =5 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
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.
Minimum Flow Area
Minimum flow area as defined in TROFI I, measured by OCT

Secondary Outcome Measures

Total Death
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
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
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 : 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): Symptoms of ischemia ECG changes indicative of new ischemia (new ST-T changes or new LBBB) Development of pathological Q waves in the ECG Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality Sudden, unexpected cardiac death, involving cardiac arrest.
Stent thrombosis
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
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
All PCI or coronary bypass grafting of non index vessel
Stable angina
Angina as reported by patient, classified according to Canadian cardiac society class (CCS)
Vascular cerebral events
Vascular events documented by neurological permanent disabilities or by diagnostic imaging (MRI or CT).
Admission for congestive heart failure or arrhythmias
Admissions were the diagnosis at release is one of heart failure or arrhythmias
Optical Coherence tomography
Area stenosis
Angiographic endpoints at index admission
TIMI flow pre and post PCI
Biochemical
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
Plasma, full blood, serum and urine will be drawn immediately after the procedure and frozen in a bio bank for later analysis
Thrombus analysis
Visible thrombus aspirates will be sent for analysis
Optical coherence tomography
Lumen late loss
Optical coherence tomography
Crushed stent segments
Optical coherence tomography
Malposition of stent segments
Optical coherence tomography
Minimum expansion of stent struts expressed as absolute area and percentage of closest reference reference area
Optical coherence tomography
Vessel ostial stented area (acute and at FU)
Optical coherence tomography
Thrombus burden
Angiographic endpoints at index admission
Blush grade
Angiographic endpoints at index admission
Thrombus burden
Angiographic endpoints at index admission
Angiographic complications
Angiographic endpoints at index admission
Contrast use
Angiographic endpoints at index admission
Procedure time
Angiographic endpoints at index admission
Radiation skin dose

Full Information

First Posted
February 11, 2014
Last Updated
May 26, 2017
Sponsor
Haukeland University Hospital
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
search

1. Study Identification

Unique Protocol Identification Number
NCT02067091
Brief Title
Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct
Acronym
BVS in STEMI
Official Title
Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct (BVS in STEMI)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute ST Segment Elevation Myocardial Infarction
Keywords
STEMI, Coronary, Bioresorbable scaffold, Drug eluting stent, Optical coherence tomography, Multislice computed tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BVS
Arm Type
Active Comparator
Arm Description
Implantation of bioresorbable vascular scaffold in coronary artery by direct stenting after thrombus aspiration by percutaneous coronary intervention
Arm Title
DES
Arm Type
Active Comparator
Arm Description
Implantation of drug eluting stent in coronary artery by direct stenting after thrombus aspiration by percutaneous coronary intervention
Intervention Type
Device
Intervention Name(s)
stent implant in a coronary artery
Intervention Description
Implantation of device called a stent in a coronary artery Percutaneous coronary intervention
Primary Outcome Measure Information:
Title
Coronary Stent Healing Index (cumulated)
Description
Uncovered struts: 2% =1 - 5% =2 - 10% =3 - 15% =4 - 20% =5 - 25% =6 - 30% =7 - 35% =8 - 40% =9 Uncovered struts in front of side branch on acquired or persistent malposed struts. 10% =1 - 20% =2 - 30% =3 etc… til 100%=10 Persistent malposition: ≥2 nabo struts længde mindst 1 mm =1 ; ≥2mm=3 ; ≥3 mm = 3 Acquired malposition: ≥2 adjacent struts of at least 1 mm length =2 ; ≥2mm=4 ; ≥3 mm = 6 Neointimal thickness in one frame >200 =1 - >300 =2 - >400 =3 or diameter stenosis >50% =4 - > 75% =5 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
Time Frame
12 months
Title
Multislice computed tomography
Description
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.
Time Frame
24 months
Title
Minimum Flow Area
Description
Minimum flow area as defined in TROFI I, measured by OCT
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Total Death
Description
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.
Time Frame
5 years
Title
Cardiac death
Description
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.
Time Frame
5 years
Title
Myocardial infarction
Description
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 : 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): Symptoms of ischemia ECG changes indicative of new ischemia (new ST-T changes or new LBBB) Development of pathological Q waves in the ECG Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality Sudden, unexpected cardiac death, involving cardiac arrest.
Time Frame
5 years
Title
Stent thrombosis
Description
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).
Time Frame
5 years
Title
Target Lesion and vessel Revascularization
Description
Coronary artery bypass grafting with grafting or PCI of index lesion. Coronary artery bypass grafting with grafting or PCI of index vessel.
Time Frame
5 years
Title
Non Target vessel revascularisation
Description
All PCI or coronary bypass grafting of non index vessel
Time Frame
5 years
Title
Stable angina
Description
Angina as reported by patient, classified according to Canadian cardiac society class (CCS)
Time Frame
5 years
Title
Vascular cerebral events
Description
Vascular events documented by neurological permanent disabilities or by diagnostic imaging (MRI or CT).
Time Frame
5 years
Title
Admission for congestive heart failure or arrhythmias
Description
Admissions were the diagnosis at release is one of heart failure or arrhythmias
Time Frame
5 years
Title
Optical Coherence tomography
Description
Area stenosis
Time Frame
12 months
Title
Angiographic endpoints at index admission
Description
TIMI flow pre and post PCI
Time Frame
After index procedure were the patient is included and randomized
Title
Biochemical
Description
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
Time Frame
12 months
Title
Markers
Description
Plasma, full blood, serum and urine will be drawn immediately after the procedure and frozen in a bio bank for later analysis
Time Frame
12 months
Title
Thrombus analysis
Description
Visible thrombus aspirates will be sent for analysis
Time Frame
At index procedure were the patient is included and randomized
Title
Optical coherence tomography
Description
Lumen late loss
Time Frame
12 months
Title
Optical coherence tomography
Description
Crushed stent segments
Time Frame
12 months
Title
Optical coherence tomography
Description
Malposition of stent segments
Time Frame
12 months
Title
Optical coherence tomography
Description
Minimum expansion of stent struts expressed as absolute area and percentage of closest reference reference area
Time Frame
12 months
Title
Optical coherence tomography
Description
Vessel ostial stented area (acute and at FU)
Time Frame
12 months
Title
Optical coherence tomography
Description
Thrombus burden
Time Frame
12 months
Title
Angiographic endpoints at index admission
Description
Blush grade
Time Frame
After index procedure were the patient is included and randomized
Title
Angiographic endpoints at index admission
Description
Thrombus burden
Time Frame
After index procedure were the patient is included and randomized
Title
Angiographic endpoints at index admission
Description
Angiographic complications
Time Frame
After index procedure were the patient is included and randomized
Title
Angiographic endpoints at index admission
Description
Contrast use
Time Frame
After index procedure were the patient is included and randomized
Title
Angiographic endpoints at index admission
Description
Procedure time
Time Frame
After index procedure were the patient is included and randomized
Title
Angiographic endpoints at index admission
Description
Radiation skin dose
Time Frame
After index procedure were the patient is included and randomized

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of chest pain < 12 hrs 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). Clinical decision to treat with primary PCI > 18 years Oral informed consent Exclusion Criteria: Contraindications to long term double antiplatelet therapy Known kidney failure with GFR < 45 Cardiac arrest or severe cardiogenic shock (Persistent BP <90 mmHg, despite adequate treatment) Other severe illness with life expectancy of less than 12 months (eg. malignancy, severe malnutrition, degenerative disease) Procedural contraindications: Heavy calcification, tortuous vessel or large side branch (> 2,5 mm) at culprit lesion. TIMI 0-1 flow after aspiration Unable to advance thrombus aspiration catheter
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vegard Tuseth, PhD
Organizational Affiliation
University of Bergen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jan Erik Nordrehaug, PhD
Organizational Affiliation
University of Bergen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Erlend Eriksen, MD
Organizational Affiliation
Helse-Bergen HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital, Skejby
City
Aarhus
Country
Denmark
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct

We'll reach out to this number within 24 hrs