Covered Stents in Treatment of Coronary Artery Perforation | NCT04630314

Studies
Covered Stents in Treatment of Coronary Artery Perforation

NCT04630314

Sponsor

Medical University of Silesia

Status

Completed

Last Update Posted

Nov 16, 2020Actual

Enrollment

119Actual

Phase

Not provided

Conditions

Coronary Artery Perforation

Interventions

Percutaneus Coronary Intervention

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2009Actual

Primary Completion Date

Nov 1, 2019Actual

Completion Date

Nov 1, 2020Actual

First Submitted Date

Nov 13, 2020

First Submission Date that Met QC Criteria

Nov 13, 2020

First Posted Date

Nov 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2020

Last Update Posted Date

Nov 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Covered stents have been mainly used for treatment of potentially life-threatening coronary artery perforation and coronary artery aneurysm. Prior studies suggest that the use of covered stents improves event-free survival, enabling a life-threatening situation to be managed without emergency surgery and with significantly reduced rates of mortality, cardiac tamponade, and major adverse cardiac events. Although the devices are used for a long time, very limited study has described procedural-related outcomes with this specific technology. We therefore want to report procedural, in-hospital and long term outcomes among patients treated with the covered stents.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

119Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Consecutive patients treated with covered stents post PCI CAP			Device: Percutaneus Coronary Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Percutaneus Coronary Intervention	Device	Covered Stent	Consecutive patients treated with covered stents post PCI CAP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major Adverse Cardiac Events (MACE)	MACE	1 year

Secondary Outcomes

Measure	Description	Time Frame
Stent Thrombosis (ST)	ST	1 year
Cardiac Death	CV Death	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Iatrogenic, peri-PCI CAP treated with covered stent implantation

Exclusion Criteria:

CAP caused due to other cause than PCI
PCI of other vascular territories during the same procedure

Accepts Healthy Volunteers

Not provided

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All consecutive patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Invasive Cardiology, Medical University of Białystok		Bialystok			Poland
First Department of Cardiology, Medical University of Gdansk