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OpenTrials
Completed

NCT Number: NCT03544294

veRy Thin Stents for Patients With Left mAIn or bifurcatioN in Real Life: the RAIN a Multicenter Study

For permanent coronary stents, reduction of thickness of struts have become one of the most important innovation, being related to easier manipulation, reduced risk of stent thrombosis and low rate of revascularization. Consequently the investigators performed a multicenter registry enrolling all consecutive patients treated with very thin stents for ULM or bifurcation.

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Key information

Conditions

Stent Restenosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Bifurcations Coronary Disease Heart Diseases Left Main Coronary Artery Disease Myocardial Ischemia Stent Thrombosis Vascular Diseases Very Thin Stents

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Citta della Salute

Turin, 10128, Italy

About this study

For permanent coronary stents, reduction of thickness of struts have become one of the most important innovation, being related to easier manipulation, reduced risk of stent thrombosis and low rate of revascularization. Previous studies do not have enough power to detect potential significant difference for ULM or bifurcation lesions. Consequently the investigators performed a multicenter registry enrolling all consecutive patients treated with Biomatrix Flex, Xience Alpine, Ultimaster, Resolute Onyx and Synergy. MACE (a composite end point of death, myocardial infarction, target lesion revascularization and stent thrombosis) will be the primary end point, while its single components will be the secondary ones.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing PCI on unprotected left main or coronary bifurcation

Exclusion criteria

  • PCI performed on other coronary vessels

Treatment and study plan

Xience alpine, ultimaster, resolute onyx, synergy

Device

PCI will be performed

Primary outcomes

  1. Major Adverse Cardiac Events (MACE)

    Time frame: 1 year

    Major Adverse Cardiac Events (MACE) is a composite end-point which includes: death for any cause; non fatal myocardial infarction; target lesion revascularization (TLR); in-stent thrombosis.

Secondary outcomes

  1. Target Lesion revascularization (TLR)

    Time frame: 1 year

    The investigators defined Target Lesion Revascularization as either repeat percutaneous or surgical revascularization for a lesion anywhere within the stent or the 5-mm borders proximal or distal to the stent.

  2. Death

    Time frame: 1 year

    Death for any cause (both cardiologic and non-cardiologic)

  3. non fatal myocardial infarction

    Time frame: 1 year

    non fatal myocardial infarction

  4. Target Vessel Revascularization (TVR)

    Time frame: 1 year

    TVR is defined as any repeat PCI in the target vessel indicating the disease progression.

Sponsors and collaborators

Lead sponsor

A.O.U. Città della Salute e della Scienza

Other

Collaborators

  • University Hospital, Zürich

Registry information

Acronym: RAIN

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2018
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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