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Invest-CTO PCI Trial

Sponsor
Haukeland University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04774913
Collaborator
Golden Jubilee National Hospital (Other)
200
Enrollment
2
Locations
1
Arm
57.8
Anticipated Duration (Months)
100
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

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

  1. A planned investment procedure in the treatment of CTOs will be associated with improved patient safety

  2. A planned investment procedure will be associated with improved cumulative procedure success rates

  3. A planned two stage procedure will be associated with improved patient experience

Condition or Disease Intervention/Treatment Phase
  • Procedure: Chronic total occlusion(CTO) percutaneous coronary intervention (PCI)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, single arm, international, multicenter studyProspective, single arm, international, multicenter study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Invest-CTO: Effectiveness and Safety of a Planned Investment Procedure in High-Risk CTO PCI
Actual Study Start Date :
Dec 8, 2021
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Oct 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Invest CTO PCI

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

Procedure: Chronic total occlusion(CTO) percutaneous coronary intervention (PCI)
CTO PCI completed as a two step procedure with an initial planned CTO modification and a completion procedure after 8-12 weeks

Outcome Measures

Primary Outcome Measures

  1. Effectiveness [Up to 12 weeks]

    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]

  2. Compositie safety endpoint [30 days post procedure]

    Death, myocardial infarction and procedural related complications

Secondary Outcome Measures

  1. CTO PCI technical success [At the end of staged CTO PCI completion procedure and within 3 months]

    Technical success is restoration of TIMI >=2 antegrade flow with <30% residual diameter stenosis within the CTO segment

  2. CTO PCI investment procedural success [30 days post procedure]

    Investment complete technical success

  3. Composite Clinical endpoint [30 days, 3 & 12 months]

    Cardiac death, MI , cardiovascular hospitalization and target vessel revascularization.

  4. European Quality of Life-5 Dimensions [Baseline, 3 and 12 months]

    5 item measure of mobility, self-care, usual activity, pain or discomfort, and anxiety or depression . Score 0-100, where high score better.

  5. Seattle angina questionnaire (SAQ7) [Baseline, 3 & 12 months]

    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.

  6. Patient related outcome measures (PROM) [Through study completion, an average of 15 months.]

    Qualitative interviews

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Haukeland University Hospital Bergen Norway 5021
2 Golden Jubilee National Hospital Glasgow United Kingdom G814DY

Sponsors and Collaborators

  • Haukeland University Hospital
  • Golden Jubilee National Hospital

Investigators

  • Principal Investigator: Margaret B Mcentegart, PhD, Golden Jubilee National Hospital
  • Principal Investigator: Anja Øksnes, MD, Haukeland University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT04774913
Other Study ID Numbers:
  • 195282
First Posted:
Mar 1, 2021
Last Update Posted:
Dec 9, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Haukeland University Hospital
Percutaneous coronary intervention
Additional relevant MeSH terms:
Angina Pectoris

Study Results

No Results Posted as of Dec 9, 2021