Clinical trial NCT04774913: Invest-CTO PCI Trial
Official title: Invest-CTO: Effectiveness and Safety of a Planned Investment Procedure in High-Risk CTO PCI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Total Occlusion of Coronary Artery
Angina Pectoris
Quality of Life
PROM
Keywords: Percutaneous coronary intervention
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Golden Jubilee National Hospital
First posted: 2021-03-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single arm, international, multicenter study
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Effectiveness
timeFrame: Up to 12 weeks
measure: Compositie safety endpoint
timeFrame: 30 days post procedure
Secondary outcomes:
measure: CTO PCI technical success
timeFrame: At the end of staged CTO PCI completion procedure and within 3 months
measure: CTO PCI investment procedural success
timeFrame: 30 days post procedure
measure: Composite Clinical endpoint
timeFrame: 30 days, 3 & 12 months
measure: European Quality of Life-5 Dimensions
timeFrame: Baseline, 3 and 12 months
measure: Seattle angina questionnaire (SAQ7)
timeFrame: Baseline, 3 & 12 months
measure: Patient related outcome measures (PROM)
timeFrame: Through study completion, an average of 15 months.
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center/ NewYork Presbyterian Hospital
state: New York
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Bristol
country: United Kingdom
facility: Bristol Health
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: London
country: United Kingdom
facility: St George´s Hospital
Study officials:
affiliation: Golden Jubilee National Hospital
name: Margaret B Mcentegart, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haukeland University Hospital
name: Anja Øksnes, MD
role: PRINCIPAL_INVESTIGATOR
References: