OCT Guided Magmaris RMS in STEMI | NCT03955731

Studies
OCT Guided Magmaris RMS in STEMI

NCT03955731

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Recruiting

Last Update Posted

Jul 3, 2024Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

STEMI

Interventions

Magmaris resorbable magnesium scaffold

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2019Actual

Primary Completion Date

Feb 15, 2025Estimated

Completion Date

Feb 15, 2025Estimated

First Submitted Date

Feb 11, 2019

First Submission Date that Met QC Criteria

May 16, 2019

First Posted Date

May 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2024

Last Update Posted Date

Jul 3, 2024Actual

Name	Class
Centre Hospitalier Universitaire Saint Pierre	OTHER
Universitair Ziekenhuis Brussel	OTHER
CHU de Charleroi	OTHER
Jolimont

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Percutaneous treatment of coronary artery disease depends on the implantation of stents within diseased coronary segments. Compared with conventional bare-metal and drug- eluting stents, which remain permanently within the coronary anatomy, bioresorbable scaffolds (BRS) offer several potential advantages due to its resorbable properties. The resorbable magnesium scaffold Magmaris has demonstrated favourable outcomes in patients with stable coronary artery disease. In particular, in comparison to polymeric bioresorbable scaffolds, no cases of stent thrombosis have been reported in over two years of follow-up suggesting that magnesium-based resorbable scaffolds have low thrombogenicity and might be particularly beneficial for patients presenting with ST- segment myocardial infarction. A recent pilot study in eighteen patients supports this concept, which has led to the development of the proposed prospective multicentre study including intra-coronary imaging with long-term clinical follow-up.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single study arm	Other	STEMI Patients treated with Magmaris resorbable magnesium scaffold	Device: Magmaris resorbable magnesium scaffold

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magmaris resorbable magnesium scaffold	Device	Implantation of Magmaris resorbable magnesium scaffold	Single study arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
A device oriented composite endpoint (DOCE) including cardiac death, target vessel myocardial infarction (attributable to the culprit lesion) and ischemic-driven target lesion revascularization (TLR) within 12 months after the index procedure.	DOCE at 12 months	1 year

Secondary Outcomes

Measure	Description	Time Frame
Procedural success defined as the delivery and deployment of RMS at the intended target lesion with a final residual stenosis ≤20% by visual estimation.	Procedure succes	in-hospital
DOCE at 1-,6- and 24-months follow-up periods.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptoms onset <24 hours or with ongoing symptoms.
Signed patient informed consent.

Exclusion Criteria:

Age < 18 or > 70 years.
Pregnancy or breastfeeding.
Cardiogenic shock.
Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis. Note: chronic dialysis dependent patients are eligible for enrolment regardless of creatinine clearance.
Infarct-artery reference diameter < 2.7 or > 4.0 mm (within the segment of the culprit lesion) by visual estimation, and OCT infarct-artery distal reference mean lumen diameter < 2.7 or > 3.7 mm
Non-optimal vessel preparation after predilatation: residual stenosis >30%.
Culprit lesion length > 21 mm.
Culprit lesion located within a previously stented segment (stent thrombosis or in-stent restenosis).
Culprit lesion involving a saphenous vein graft.
Culprit lesion involving a bifurcation with an intended two-stent implantation strategy.
Ostial right coronary artery
Severe calcification or tortuosity of the infarct-related artery.
Absolute contraindication to a 12 months dual antiplatelet therapy.
Life expectancy < 3 years.
Patients taking oral anticoagulant therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Johan Bennett, Dr.	Contact	+3216342465		johan.bennett@uzleuven.be

Facility	Status	City	State	ZIP	Country	Contacts
Johan Bennett	Recruiting	Leuven	Brabant	3001	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D000072657	ST Elevation Myocardial Infarction

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

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