- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02067091
Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct (BVS in STEMI)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: BVS
Implantation of bioresorbable vascular scaffold in coronary artery by direct stenting after thrombus aspiration by percutaneous coronary intervention
|
Implantation of device called a stent in a coronary artery Percutaneous coronary intervention |
Active Comparator: DES
Implantation of drug eluting stent in coronary artery by direct stenting after thrombus aspiration by percutaneous coronary intervention
|
Implantation of device called a stent in a coronary artery Percutaneous coronary intervention |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coronary Stent Healing Index (cumulated)
Time Frame: 12 months
|
|
12 months
|
Multislice computed tomography
Time Frame: 24 months
|
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.
|
24 months
|
Minimum Flow Area
Time Frame: 12 months
|
Minimum flow area as defined in TROFI I, measured by OCT
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Death
Time Frame: 5 years
|
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.
|
5 years
|
Cardiac death
Time Frame: 5 years
|
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.
|
5 years
|
Myocardial infarction
Time Frame: 5 years
|
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 :
|
5 years
|
Stent thrombosis
Time Frame: 5 years
|
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).
|
5 years
|
Target Lesion and vessel Revascularization
Time Frame: 5 years
|
Coronary artery bypass grafting with grafting or PCI of index lesion.
Coronary artery bypass grafting with grafting or PCI of index vessel.
|
5 years
|
Non Target vessel revascularisation
Time Frame: 5 years
|
All PCI or coronary bypass grafting of non index vessel
|
5 years
|
Stable angina
Time Frame: 5 years
|
Angina as reported by patient, classified according to Canadian cardiac society class (CCS)
|
5 years
|
Vascular cerebral events
Time Frame: 5 years
|
Vascular events documented by neurological permanent disabilities or by diagnostic imaging (MRI or CT).
|
5 years
|
Admission for congestive heart failure or arrhythmias
Time Frame: 5 years
|
Admissions were the diagnosis at release is one of heart failure or arrhythmias
|
5 years
|
Optical Coherence tomography
Time Frame: 12 months
|
Area stenosis
|
12 months
|
Angiographic endpoints at index admission
Time Frame: After index procedure were the patient is included and randomized
|
TIMI flow pre and post PCI
|
After index procedure were the patient is included and randomized
|
Biochemical
Time Frame: 12 months
|
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
|
12 months
|
Markers
Time Frame: 12 months
|
Plasma, full blood, serum and urine will be drawn immediately after the procedure and frozen in a bio bank for later analysis
|
12 months
|
Thrombus analysis
Time Frame: At index procedure were the patient is included and randomized
|
Visible thrombus aspirates will be sent for analysis
|
At index procedure were the patient is included and randomized
|
Optical coherence tomography
Time Frame: 12 months
|
Lumen late loss
|
12 months
|
Optical coherence tomography
Time Frame: 12 months
|
Crushed stent segments
|
12 months
|
Optical coherence tomography
Time Frame: 12 months
|
Malposition of stent segments
|
12 months
|
Optical coherence tomography
Time Frame: 12 months
|
Minimum expansion of stent struts expressed as absolute area and percentage of closest reference reference area
|
12 months
|
Optical coherence tomography
Time Frame: 12 months
|
Vessel ostial stented area (acute and at FU)
|
12 months
|
Optical coherence tomography
Time Frame: 12 months
|
Thrombus burden
|
12 months
|
Angiographic endpoints at index admission
Time Frame: After index procedure were the patient is included and randomized
|
Blush grade
|
After index procedure were the patient is included and randomized
|
Angiographic endpoints at index admission
Time Frame: After index procedure were the patient is included and randomized
|
Thrombus burden
|
After index procedure were the patient is included and randomized
|
Angiographic endpoints at index admission
Time Frame: After index procedure were the patient is included and randomized
|
Angiographic complications
|
After index procedure were the patient is included and randomized
|
Angiographic endpoints at index admission
Time Frame: After index procedure were the patient is included and randomized
|
Contrast use
|
After index procedure were the patient is included and randomized
|
Angiographic endpoints at index admission
Time Frame: After index procedure were the patient is included and randomized
|
Procedure time
|
After index procedure were the patient is included and randomized
|
Angiographic endpoints at index admission
Time Frame: After index procedure were the patient is included and randomized
|
Radiation skin dose
|
After index procedure were the patient is included and randomized
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/2006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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