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

NCT02067091 | Unknown Phase 3 DMC

• 1 other identifier: 2013/2006
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

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.

Conditions

Acute ST Segment Elevation Myocardial Infarction

Keywords

STEMI; Coronary; Bioresorbable scaffold; Drug eluting stent; Optical coherence tomography; Multislice computed tomography

Outcome Measures

Primary Outcomes (3)

• Coronary Stent Healing Index (cumulated)

  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

  12 months

• 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.

  24 months

• Minimum Flow Area

  Minimum flow area as defined in TROFI I, measured by OCT

  12 months

Secondary Outcomes (26)

• Total Death

  5 years

• Cardiac death

  5 years

• Myocardial infarction

  5 years

• Stent thrombosis

  5 years

• Target Lesion and vessel Revascularization

  5 years

Study Arms (2)

BVS

ACTIVE COMPARATOR

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

Device: stent implant in a coronary artery

DES

ACTIVE COMPARATOR

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

Device: stent implant in a coronary artery

Interventions

stent implant in a coronary artery DEVICE

Implantation of device called a stent in a coronary artery Percutaneous coronary intervention

BVS; DES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Aarhus University Hospital Skejby: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Oslo University Hospital: collaborator
• St. Olavs Hospital: collaborator
• University Hospital of North Norway: collaborator
• Feiring: collaborator

Study Sites (2)

Aarhus University Hospital, Skejby

Aarhus, Denmark

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Stents

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Vegard Tuseth, PhD

  University of Bergen

  STUDY CHAIR

• Jan Erik Nordrehaug, PhD

  University of Bergen

  STUDY CHAIR

• Erlend Eriksen, MD

  Helse-Bergen HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 20, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: August 1, 2020
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

DK (1); NO (1)