European Registry On Plaque ModifiCAtion in the STEMI Population (ROCA-STEMI)

NCT05752617 | Unknown

• 1 other identifier: 2020/9525
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is an European prospective cohort study from February 2023 until February 2024. The investigators want to analyze the clinical success, efficacy and safety of consecutive patients who presented with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) for de novo heavily calcified culprit lesion using plaque modification devices before stent implantation.

Conditions

Calcified Coronary Lesions; ST Elevated Myocardial Infarction; Plaque Modification Technique

Outcome Measures

Primary Outcomes (1)

• Target Vessel Failure

  The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization.

  12 months

Secondary Outcomes (4)

• Cardiac death

  12 months

• Major Adverse Cardiac Events (MACE)

  12 months

• Target vessel revascularization

  12 months

• Target lesion revascularization

  12 months

Eligibility Criteria

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

Study Population

The ROCA-STEMI study is an European prospective cohort study from February 2023 until February 2024. We want to analyze the clinical success, efficacy and safety of consecutive patients who presented with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) for de novo heavily calcified culprit lesion using plaque modification devices before stent implantation.

You may qualify if:

• Age ≥ 18 years
• Patient with a STEMI
• Primary percutaneous coronary intervention
• De-novo culprit lesion in a native coronary artery
• Severe calcification of the target lesion or its equivalent (balloon uncrossable or undilatable lesion) (See Definitions 4.4)
• Mandatory use of a plaque modification device to treat the culprit lesion (See Study device and procedures 4.5)
• The patient or legal representative signing an informed written consent

You may not qualify if:

• The target vessel had a stent from a previous PCI
• The target lesion was treated as a staged procedure
• Pregnant women
• Terminally ill patients

Sponsors & Collaborators

• Hospital del Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Related Publications (29)

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MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 2, 2023
• Study Start: February 15, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 2, 2023

Record last verified: 2023-03

Locations

ES (1)