NCT03756870: REVISE-CTO

Revascularization Versus Optimal Medical Therapy of Chronic Total Coronary Occlusions on Left Ventricular Ischemia Reduction

Recruiting now NA Last updated 20 July 2023

What this trial tests

NA trial testing Percutaneous coronary intervention (PCI) in Chronic Total Occlusion of Coronary Artery in 82 participants. Currently enrolling.

Timeline

1 July 2019

Primary endpoint
1 January 2024

1 January 2030

Quick facts

Lead sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	82
Start date	1 July 2019
Primary completion	1 January 2024
Estimated completion	1 January 2030
Sites	1 location across Netherlands

Drugs / interventions tested

• Percutaneous coronary intervention (PCI)

Conditions studied

• Chronic Total Occlusion of Coronary Artery — all drugs for Chronic Total Occlusion of Coronary Artery →

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

18 and older, any sex, with Chronic Total Occlusion of Coronary Artery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale: Randomized trials could not yet establish favourable outcomes of CTO PCI on hard endpoints such as ejection fraction or mortality, when compared to optimal medical therapy. However, patients after CTO PCI appeared to be more frequently free of angina complaints, but the aetiology behind this is not fully understood. The investigators hypothesize that PCI of the CTO in patients preselected with an ischemic threshold (\>12.5%) on cardiac imaging leads to a reduction of the ischemic burden and therefore an increased benefit on functional outcomes.

Objective: Primary objective is to determine whether PCI of the CTO will yield a higher reduction of ischemia assessed by exercise myocardial perfusion SPECT-CT from baseline to 6-month follow-up compared to a control group. Secondary objectives are 1) to evaluate the effect of PCI of the CTO on improvement in functional status, infarct size and left ventricular function from baseline to follow-up compared to the control group; 2) to study the association between ischemia reduction and functional outcome and left ventricular function; 3) to assess the influence of the collateral flow index on the ischemic burden (reduction), functional status, infarct size and left ventricular (contractile) function (hibernation).

Study design: open multicentre randomized trial

Study population: 82 patients eligible for CTO PCI

Intervention: CTO PCI

Primary endpoint: ischemic burden assessed with exercise myocardial perfusion SPECT-CT from baseline to 6 months follow-up.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Percutaneous coronary intervention versus medical therapy for chronic total coronary occlusions: a systematic review and meta-analysis of randomised trials.
   van Veelen A, Elias J, van Dongen IM, Hoebers LPC, et al · · 2021 · cited 12× · PMID 33064274 · DOI 10.1007/s12471-020-01503-0
2. Ten-Year Outcome of Recanalization or Medical Therapy for Concomitant Chronic Total Occlusion After Myocardial Infarction.
   van Veelen A, Coerkamp CF, Somsen YBO, Råmunddal T, et al · · 2024 · cited 8× · PMID 38726918 · DOI 10.1161/jaha.123.033556
3. Myocardial perfusion imaging in advanced coronary artery disease.
   Hoek R, van Diemen PA, Somsen YBO, de Winter RW, et al · · 2025 · cited 5× · PMID 40099580 · DOI 10.1111/eci.70024