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Invest-CTO PCI Trial

Primary Purpose

Chronic Total Occlusion of Coronary Artery, Angina Pectoris, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Chronic total occlusion(CTO) percutaneous coronary intervention (PCI)
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Total Occlusion of Coronary Artery focused on measuring Percutaneous coronary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to provide written informed consent
  • Comply with the procedural and study follow-up schedule
  • Planned CTO PCI in accordance with the European and American appropriateness criteria.
  • CTO defined as high-risk

Exclusion Criteria:

  • Non-high risk CTO
  • Occlusion within a stent
  • Flush aorto-ostial occlusion of RCA and Left Main (LMS)
  • Limited arterial access precluding repeat procedure
  • Baseline non invasive testing showing non-viable target vessel territory
  • Contra-indication to dual antiplatelet therapy
  • Pregnancy
  • Prior radiation skin injury
  • Lack of informed consent

Sites / Locations

  • Haukeland University HospitalRecruiting
  • Golden Jubilee National HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Invest CTO PCI

Arm Description

A pre-planned two staged procedure in high-risk CTO PCI

Outcomes

Primary Outcome Measures

Effectiveness
CTO PCI Procedural success, Complete technical success plus the absence of an in-hospital major adverse cardiovascular event (MACE; death, MI, or clinically driven target vessel revascularization [TVR]
Compositie safety endpoint
Death, myocardial infarction and procedural related complications

Secondary Outcome Measures

CTO PCI technical success
Technical success is restoration of TIMI >=2 antegrade flow with <30% residual diameter stenosis within the CTO segment
CTO PCI investment procedural success
Investment complete technical success
Composite Clinical endpoint
Cardiac death, MI , cardiovascular hospitalization and target vessel revascularization.
European Quality of Life-5 Dimensions
5 item measure of mobility, self-care, usual activity, pain or discomfort, and anxiety or depression . Score 0-100, where high score better.
Seattle angina questionnaire (SAQ7)
3 domain score of physical limitation (SAQ7-PL), angina frequency (SAQ7-AF) and quality of life (SAQ7-QL). Score 0-100, where high score better.
Patient related outcome measures (PROM)
Qualitative interviews

Full Information

First Posted
February 17, 2021
Last Updated
August 30, 2023
Sponsor
Haukeland University Hospital
Collaborators
Golden Jubilee National Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04774913
Brief Title
Invest-CTO PCI Trial
Official Title
Invest-CTO: Effectiveness and Safety of a Planned Investment Procedure in High-Risk CTO PCI
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
Golden Jubilee National Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Following unsuccessful CTO crossing a CTO modification procedure is sometimes performed. CTO PCI registries where plaque modification has been performed in some patients, report this to be safe, and associated with higher success rates at subsequent attempts. It has never been investigated whether a planned investment procedure, with an intention that both the initial and staged completion PCI are of shorter duration, could improve safety and efficacy. The investigators hypothesize that A planned investment procedure in the treatment of CTOs will be associated with improved patient safety A planned investment procedure will be associated with improved cumulative procedure success rates A planned two stage procedure will be associated with improved patient experience

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Total Occlusion of Coronary Artery, Angina Pectoris, Quality of Life, PROM
Keywords
Percutaneous coronary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, single arm, international, multicenter study
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Invest CTO PCI
Arm Type
Experimental
Arm Description
A pre-planned two staged procedure in high-risk CTO PCI
Intervention Type
Procedure
Intervention Name(s)
Chronic total occlusion(CTO) percutaneous coronary intervention (PCI)
Intervention Description
CTO PCI completed as a two step procedure with an initial planned CTO modification and a completion procedure after 8-12 weeks
Primary Outcome Measure Information:
Title
Effectiveness
Description
CTO PCI Procedural success, Complete technical success plus the absence of an in-hospital major adverse cardiovascular event (MACE; death, MI, or clinically driven target vessel revascularization [TVR]
Time Frame
Up to 12 weeks
Title
Compositie safety endpoint
Description
Death, myocardial infarction and procedural related complications
Time Frame
30 days post procedure
Secondary Outcome Measure Information:
Title
CTO PCI technical success
Description
Technical success is restoration of TIMI >=2 antegrade flow with <30% residual diameter stenosis within the CTO segment
Time Frame
At the end of staged CTO PCI completion procedure and within 3 months
Title
CTO PCI investment procedural success
Description
Investment complete technical success
Time Frame
30 days post procedure
Title
Composite Clinical endpoint
Description
Cardiac death, MI , cardiovascular hospitalization and target vessel revascularization.
Time Frame
30 days, 3 & 12 months
Title
European Quality of Life-5 Dimensions
Description
5 item measure of mobility, self-care, usual activity, pain or discomfort, and anxiety or depression . Score 0-100, where high score better.
Time Frame
Baseline, 3 and 12 months
Title
Seattle angina questionnaire (SAQ7)
Description
3 domain score of physical limitation (SAQ7-PL), angina frequency (SAQ7-AF) and quality of life (SAQ7-QL). Score 0-100, where high score better.
Time Frame
Baseline, 3 & 12 months
Title
Patient related outcome measures (PROM)
Description
Qualitative interviews
Time Frame
Through study completion, an average of 15 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to provide written informed consent Comply with the procedural and study follow-up schedule Planned CTO PCI in accordance with the European and American appropriateness criteria. CTO defined as high-risk Exclusion Criteria: Non-high risk CTO Occlusion within a stent Flush aorto-ostial occlusion of RCA and Left Main (LMS) Limited arterial access precluding repeat procedure Baseline non invasive testing showing non-viable target vessel territory Contra-indication to dual antiplatelet therapy Pregnancy Prior radiation skin injury Lack of informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anja Øksnes, MD
Phone
+4755975000
Email
anao@helse-bergen.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret B Mcentegart, PhD
Organizational Affiliation
Golden Jubilee National Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anja Øksnes, MD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anja Øksnes, MD
Phone
+4755972191
Email
anao@helse-bergen.no
Facility Name
Golden Jubilee National Hospital
City
Glasgow
ZIP/Postal Code
G814DY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret B Mcentegart, PhD
Phone
0141 951 5000
Email
Margaret.mcentegart@gjnh.scot.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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Invest-CTO PCI Trial

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