Plaque stabilization and restoration of vascular function by bioresorbable vascular scaffold in acute coronary syndrome prone patients

Plaque stabilization and restoration of vascular function by bioresorbable vascular scaffold in acute coronary syndrome prone patients - ABSORB-PREVENT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38540

Enrollment

Registered

2014-02-28

Start date

2015-10-29

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerosis plaque

Interventions

Implantation of bioresorbable vascular scaffold.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Symptomatic patients between the age of 18 and 80 years - Morise Risk score of *9 (intermediate or high risk) but no proven ischemia (no positive troponin or ST-elevation) - Intermediate coronary lesion on CT scan (50-70% based on CT estimate) and a plaque with at least two of the following vulnerability criteria: Napkin ring sign, positive remodeling, low attenuation and spotty calcification - FFR negative lesion at coronary angiogram - Vessel diameter *2.5 mm on visual estimate

Exclusion criteria

Exclusion criteria: - High calcium score on CT scan preventing adequate evaluation of the coronary lesion. - Lesions located in a coronary vessels previously stented. - Left main (>50%) or known three vessel disease. - Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparine or Everolimus and known true anaphylaxis to prior contrast media or known bleeding diathesis or known coagulopathy.

Design outcomes

Primary

Measure	Time frame
Composite endpoint of change in plaque cumulative score of signs of vulnerability on CT and nominal change in percent necrotic core and thin-cap fibroatheroma at VH-IVUS at 24 months	—

Secondary

Measure	Time frame
A. assessment of vessel and lesion: - change in target lesion cumulative score of signs of vulnerability based on CT at 24 months - change in target plaque volume based on CT at 24 months - change in necrotic core volume based on CT at 24 months - change in positive remodelling index on CT at 24 months - change in total plaque volume on CT at 24 months - remaining target lesion stenosis based on CT at 24 months - Nominal change in in percent necrotic core and thin-cap fibroatheroma at VH-IVUS at 24 months - Remaining plaque thickness based on VH-IVUS at 24 months - Change in vessel area, lumen area, plaque area (vessel area - minus lumen area), and plaque burden [(plaque area/vessel area) × 100] at 24 months - change in plaque composition on VH-IVUS at 24 months - change in mean lumen diameter (MLD) pre and post nitroglycerine infusion based on quantative coronary analysis (QCA) at 24 months. - change in mean lumen diameter (MLD) pre and post acetylcholine infusion based on quantative coronary analysis (QCA) at 24 months. B. Safety - Successful delivery and deployment of the BVS in the intended target lesion with residual stenosis of less than 50% - Occurrence of death, (periprocedural) MI	—

Measure

Time frame

A. assessment of vessel and lesion: - change in target lesion cumulative score of signs of vulnerability based on CT at 24 months - change in target plaque volume based on CT at 24 months - change in necrotic core volume based on CT at 24 months - change in positive remodelling index on CT at 24 months - change in total plaque volume on CT at 24 months - remaining target lesion stenosis based on CT at 24 months - Nominal change in in percent necrotic core and thin-cap fibroatheroma at VH-IVUS at 24 months - Remaining plaque thickness based on VH-IVUS at 24 months - Change in vessel area, lumen area, plaque area (vessel area - minus lumen area), and plaque burden [(plaque area/vessel area) × 100] at 24 months - change in plaque composition on VH-IVUS at 24 months - change in mean lumen diameter (MLD) pre *and post nitroglycerine infusion based on quantative coronary analysis (QCA) at 24 months. - change in mean lumen diameter (MLD) pre *and post acetylcholine infusion based on quantative coronary analysis (QCA) at 24 months. B. Safety - Successful delivery and deployment of the BVS in the intended target lesion with residual stenosis of less than 50% - Occurrence of death, (periprocedural) MI

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)