Back to resultsA Randomized Comparison of Long-Term Healing Between Biodegradable- Versus Durable-Polymer Everolimus Eluting Stents in STEMI (CONNECT)
Primary Purpose
STEMI - ST Elevation Myocardial Infarction
Status
Active
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Synergy
Xience
Sponsored by
About this trial
This is an interventional treatment trial for STEMI - ST Elevation Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years
- Primary PCI within 24 hours of symptom onset
- ST-segment elevation of > 1mm in > 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >1mm in >2 contiguuoius anterior leads
- Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.5 mm in diameter that can be covered with one or multiple stents
Exclusion Criteria:
- Female ofchildbearing potential (age < 50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
- Known intolerance to aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, cobalt chromium, platinum chromium, everolimus or contrast material
- Inability to understand and provide informed consent
- Currently participating in another trial before reaching first endpoint
- Mechanical complications of acute myocardial infarction
- Acute myocardial infarction secondary to stent thrombosis or restenosis
- Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
- Noncardiac comorbid conditions are present with life expectancy <3years or that may result in protocol noncompliance
- History of bleeding diathesis or known coagulopathy
- Use of oral anticoagulation
- Age >90 years
- LV-function at index procedure <=20%
- Cancer under active treatment (chemotherapy)
- Hemodynamic instability following primary PCI
- Chronic kidey disease (Creatinine - Clearance < 30ml/min)
- OCT technically not feasible (severe calcification, tortuosity)
Sites / Locations
- Tokorozawa Heart Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Synergy
Xience
Arm Description
Biodegradable-polymer everolimus-eluting stent Synergy
Durable-polymer everolimus-eluting stent Xience
Outcomes
Primary Outcome Measures
Frequency of neoatheroslcerosis
Frequency of neoatherosclerosis lesion which is defined as the presence of a fibroatheroma or fibrocalcific plaques or macrophages within the neointima of a stented segment with a longitudinal extension of ≧ 1 mm at three years.
Secondary Outcome Measures
Athero-thrombotic material area
Athero-thrombotic material area (tissue protorusion + isolated intraluminal detect) within the stent strut after primary PCI
Full Information
NCT ID
NCT03440801
First Posted
February 12, 2018
Last Updated
May 22, 2022
Sponsor
Tokorozawa Heart Center
Collaborators
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT03440801
Brief Title
A Randomized Comparison of Long-Term Healing Between Biodegradable- Versus Durable-Polymer Everolimus Eluting Stents in STEMI
Acronym
CONNECT
Official Title
A Randomized COmparison of LoNg-Term Vascular HealiNg bEtween Biodegradable -Polymer (BP) Versus Durable Polymer (DP) Everolimus Eluting Stents in Acute ST-Elevation Myocardial InfarCTion
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 3, 2017 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokorozawa Heart Center
Collaborators
Insel Gruppe AG, University Hospital Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to compare the acute thrombogenecity and frequency of neoatherosclerotic lesions and other aspects of long term arterial healing such as the frequency of malapposed and uncovered stent struts at 3 years among patients treated with either a biodegradable polymer everolimus-eluting stent (Synergy) or a durable polymer everolimus-eluting stent (Xience Alpine) for STEMI.
Detailed Description
DES use has significantly improved clinical outcomes as compared with bare metal stents (BMS), primarily through a notable reduction in the risk of repeat revascularisation. However, durable polymer DES have been associated with an increased risk of late and very late stent thrombosis and the anticipated development of in-stent neoatherosclerosis. In addition, in-vivo study suggest that different types of polymer among current DES might have different responses to acute thrombogenecity after stent implantation.
Patients with STEMI are associated with worse long-term clinical outcomes due to re-infarction and stent thrombosis throughout long-term follow-up. Underlying unstable lesion which includes ruptured plaque and thin-cap fibroatheroma behind stent strut is a predictor of neoatherosclerosis formation.
There is no dedicated randomized trial to comparing biodegradable-polymer versus durable polymer-DES in terms of acute thrombogenecity and long-term healing at 3 years after primary PCI.
Therefore this study is designed to compare the acute thrombogenecity and frequency of neoatherosclerotic lesions and other aspects of long term arterial healing at 3 years among patients treated with either a biodegradable polymer everolimus-eluting stent (Synergy) or a durable polymer everolimus-eluting stent (Xience Alpine) for STEMI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI - ST Elevation Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Synergy
Arm Type
Experimental
Arm Description
Biodegradable-polymer everolimus-eluting stent Synergy
Arm Title
Xience
Arm Type
Active Comparator
Arm Description
Durable-polymer everolimus-eluting stent Xience
Intervention Type
Device
Intervention Name(s)
Synergy
Intervention Description
Biodegradable-polymer everolimus-eluting stent Synergy
Intervention Type
Device
Intervention Name(s)
Xience
Intervention Description
Durable-polymer everolimus-eluting stent Xience
Primary Outcome Measure Information:
Title
Frequency of neoatheroslcerosis
Description
Frequency of neoatherosclerosis lesion which is defined as the presence of a fibroatheroma or fibrocalcific plaques or macrophages within the neointima of a stented segment with a longitudinal extension of ≧ 1 mm at three years.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Athero-thrombotic material area
Description
Athero-thrombotic material area (tissue protorusion + isolated intraluminal detect) within the stent strut after primary PCI
Time Frame
initial day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years
Primary PCI within 24 hours of symptom onset
ST-segment elevation of > 1mm in > 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >1mm in >2 contiguuoius anterior leads
Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.5 mm in diameter that can be covered with one or multiple stents
Exclusion Criteria:
Female ofchildbearing potential (age < 50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
Known intolerance to aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, cobalt chromium, platinum chromium, everolimus or contrast material
Inability to understand and provide informed consent
Currently participating in another trial before reaching first endpoint
Mechanical complications of acute myocardial infarction
Acute myocardial infarction secondary to stent thrombosis or restenosis
Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
Noncardiac comorbid conditions are present with life expectancy <3years or that may result in protocol noncompliance
History of bleeding diathesis or known coagulopathy
Use of oral anticoagulation
Age >90 years
LV-function at index procedure <=20%
Cancer under active treatment (chemotherapy)
Hemodynamic instability following primary PCI
Chronic kidey disease (Creatinine - Clearance < 30ml/min)
OCT technically not feasible (severe calcification, tortuosity)
Facility Information:
Facility Name
Tokorozawa Heart Center
City
Tokorozawa
ZIP/Postal Code
3591142
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Randomized Comparison of Long-Term Healing Between Biodegradable- Versus Durable-Polymer Everolimus Eluting Stents in STEMI
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