Invest-CTO PCI Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-08

Study Completion Date

2026-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, single arm, international, multicenter study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Invest CTO PCI

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

Group Type EXPERIMENTAL

Chronic total occlusion(CTO) percutaneous coronary intervention (PCI)

Intervention Type PROCEDURE

CTO PCI completed as a two step procedure with an initial planned CTO modification and a completion procedure after 8-12 weeks

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No