NCT03563989

Brief Summary

Intro: Chronic total occlusions (CTO) are the most severe coronary lesions. Negative distal vessel remodeling occurs in these lesions, leading to reduction of artery diameter. Treatment of CTO with percutaneous coronary intervention (PCI) is associated with good clinical outcomes. However, QCA and IVUS studies showed a notable lumen and vessel enlargement distal to recanalized CTO. In addition, optical tomography (OCT) studies showed high rates of stent strut malapposition and incomplete stent strut coverage after CTO PCI. The Stentys Xposition S is a self-apposing stent device which lowers stent strut malapposition rates. Its safety and effectiveness has been demonstrated in STEMI and stable coronary patients but never investigated in CTO lesions. Hypothesis/Objective To investigate whether self-expanding stents are more effective than balloon-expandable stents for reducing stent malapposition at 6 months after implantation in patients with CTO undergoing percutaneous coronary intervention. Method Pilot randomized study. Patients are randomized to receive either self-expandable stent or balloon expandable stent to perform CTO-PCI. Follow-up coronary angiography is performed at 6 months post-PCI. Stent malapposition is evaluated by OCT.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

June 26, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 13, 2018

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

May 28, 2018

Last Update Submit

August 10, 2018

Conditions

Chronic Total OcclusionCoronary Artery Disease

Keywords

Chronic total occlusionSelf-expandable stentPercutaneous coronary interventionCoronary artery disease

Outcome Measures

Primary Outcomes (1)

  • strut malapposition at six months measured by OCT

    6 months after CTO-PCI

Secondary Outcomes (8)

  • percentage of uncovered struts

    6 months after CTO-PCI

  • lumen diameter (mm)

    6 months after CTO-PCI

  • Restenosis

    6 months after CTO-PCI

  • Angina pectoris

    6 months after CTO-PCI

  • Dyspnea

    6 months after CTO-PCI

  • +3 more secondary outcomes

Study Arms (2)

Stentys Xposition S Self-Apposing stent

EXPERIMENTAL

STENTYS Xposition S Sirolimus Eluting Self-Apposing Coronary Stent System

Device: Implantation of Stent (PCI)

Conventional Balloon-expandable stent

ACTIVE COMPARATOR

Conventional Balloon-expandable drug eluting stents in effect at the time of the study, in compliance with applicable contracts made between Hospital and suppliers.

Device: Implantation of Stent (PCI)

Interventions

Implantation of Stent (PCI)DEVICE

Treatment of CTO with Percutaneous Coronary Intervention (PCI) Patients are randomized to receive either self-expandable stent or balloon expandable stent

Conventional Balloon-expandable stentStentys Xposition S Self-Apposing stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 18 years;
  • CTO referred for PCI
  • Diameter of the Target vessel for PCI between 2.5 and 4.5mm
  • Agreement to participate and signed informed consent after information
  • Affiliation to Social Security System
  • French comprehension

You may not qualify if:

  • Pregnant women, breast-feeding,
  • History of an allergic reaction or significant sensitivity to any stent component or to contrast dye
  • Intrastent CTO
  • Major calcifications in the CTO
  • Person under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, 94010, France

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2018

First Posted

June 20, 2018

Study Start

June 26, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

August 13, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Locations

FR(1)