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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03544294
Other study ID # RAIN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2017
Est. completion date May 30, 2018

Study information

Verified date June 2018
Source Azienda Ospedaliera Città della Salute e della Scienza di Torino
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 2800
Est. completion date May 30, 2018
Est. primary completion date May 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing PCI on unprotected left main or coronary bifurcation

Exclusion Criteria:

- PCI performed on other coronary vessels

Study Design


Intervention

Device:
Xience alpine, ultimaster, resolute onyx, synergy
PCI will be performed

Locations

Country Name City State
Italy Citta della Salute Turin

Sponsors (2)

Lead Sponsor Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino University Hospital, Zürich

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major Adverse Cardiac Events (MACE) 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. 1 year
Secondary Target Lesion revascularization (TLR) 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. 1 year
Secondary Death Death for any cause (both cardiologic and non-cardiologic) 1 year
Secondary non fatal myocardial infarction non fatal myocardial infarction 1 year
Secondary Target Vessel Revascularization (TVR) TVR is defined as any repeat PCI in the target vessel indicating the disease progression. 1 year
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