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

• Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino (Other)
• Overall Status: Completed
• CT.gov ID: NCT03544294
• Collaborator: University Hospital, Zürich (Other)
• Enrollment: 2,800
• Location: 1
• Actual Duration (Months): 11.9
• Patients Per Site Per Month: 234.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stent Restenosis; Stent Thrombosis; Left Main Coronary Artery Disease; Coronary Bifurcations; Very Thin Stents	Device: Xience alpine, ultimaster, resolute onyx, synergy

Detailed 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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 2800 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: veRy Thin Stents for Patients With Left mAIn or bifurcatioN in Real Life: the RAIN a Multicenter Study
• Actual Study Start Date: Jun 1, 2017
• Actual Primary Completion Date: May 30, 2018
• Actual Study Completion Date: May 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Group Consecutive patients treated with very thin stents on ULM and bifurcation	Device: Xience alpine, ultimaster, resolute onyx, synergy; PCI will be performed

Outcome Measures

Primary Outcome Measures

1. Major Adverse Cardiac Events (MACE) [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 Outcome Measures

1. Target Lesion revascularization (TLR) [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 [1 year]

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

3. non fatal myocardial infarction [1 year]

   non fatal myocardial infarction

4. Target Vessel Revascularization (TVR) [1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients undergoing PCI on unprotected left main or coronary bifurcation

Exclusion Criteria:

• PCI performed on other coronary vessels

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Citta della Salute	Turin		Italy	10128

Sponsors and Collaborators

• Azienda Ospedaliera Città della Salute e della Scienza di Torino
• University Hospital, Zürich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fabrizio D'Ascenzo, Principal Investigator, Azienda Ospedaliera Città della Salute e della Scienza di Torino
• ClinicalTrials.gov Identifier: NCT03544294
• Other Study ID Numbers: RAIN
• First Posted: Jun 1, 2018
• Last Update Posted: Jun 6, 2018
• Last Verified: Jun 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Coronary Artery Disease; Thrombosis

Study Results

No Results Posted as of Jun 6, 2018