NCT03710070

Clinical Efficacy of Permanent Internal Mammary Artery Occlusion in Stable Coronary Artery Disease

Completed NA Last updated 14 February 2023

What this trial tests

NA trial testing Amplatzer vascular plug 4 in Coronary Artery Disease in 100 participants. Completed in 1 April 2022.

Timeline

8 March 2019

Primary endpoint
1 April 2022

1 April 2022

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	100
Start date	8 March 2019
Primary completion	1 April 2022
Estimated completion	1 April 2022
Sites	1 location across Switzerland

Drugs / interventions tested

• Amplatzer vascular plug 4
• Sham Control — full drug profile →

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• Internal Mammary-Coronary Artery Anastomosis — all drugs for Internal Mammary-Coronary Artery Anastomosis →
• Ischemia — all drugs for Ischemia →
• Circulation, Collateral — all drugs for Circulation, Collateral →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

18 and older, any sex, with Coronary Artery Disease or Internal Mammary-Coronary Artery Anastomosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cardiovascular diseases remain the number one cause of death globally, primarily consequence of myocardial infarction. Although widely used in stable coronary artery disease (CAD), percutaneous coronary intervention (PCI) has not been shown to reduce the incidence of myocardial infarction or death. In contrast, coronary artery bypass grafting (CABG) significantly reduces rates of death and myocardial infarction compared to PCI, but at a higher rate of stroke. Similarly, coronary collaterals exert a protective effect by providing an alternative source of blood flow to a myocardial territory potentially affected by an acute coronary occlusion. Coronary collaterals represent pre-existing inter-arterial anastomoses and as such are the natural counter-part of surgically created bypasses. Sufficient coronary collaterals have been shown to confer a significant benefit in terms of overall mortality and cardiovascular events. In this regard, the concept of augmenting coronary collateral function as an alternative treatment strategy to alter the course of CAD, as well as to control symptoms, is attractive.

While a multitude of interventions has been shown to be effective in collateral growth promotion, so far, the effect of current interventions is only temporary, and therefore, repeated application is necessary to sustain the level of collaterals. The prevalent in vivo function of natural internal mammary arteries (IMA)-to-coronary artery bypasses and their anti-ischemic effect has been recently demonstrated by the investigators' research group. Levels of collateral function and myocardial ischemia were determined in a prospective, open-label clinical trial of permanent IMA device occlusion. In this study, coronary collateral function, has been shown to be augmented in the presence vs the absence of distal permanent ipsilateral IMA occlusion. These findings have been corroborated by the observed reduction in ischemia in the intracoronary ECG.

Coronary functional changes observed in response to permanent distal IMA occlusion have so far, not been related to clinical outcome parameters. Therefore, a controlled, randomized, double-blind comparison of clinical efficacy between a group of patients receiving permanent IMA occlusion vs. a sham-procedure will be consequently performed. Since single antianginal agents have been demonstrated to increase exercise time in comparison to placebo, an improvement of the physical performance due to the increased blood flow by the permanent distal IMA occlusion is expected.

Publications & conference data

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

1. The Human Coronary Collateral Circulation, Its Extracardiac Anastomoses and Their Therapeutic Promotion.
   Bigler MR, Seiler C. · · 2019 · cited 23× · PMID 31366096 · DOI 10.3390/ijms20153726
2. Improving the Design of Future PCI Trials for Stable Coronary Artery Disease: JACC State-of-the-Art Review.
   Marquis-Gravel G, Moliterno DJ, Francis DP, Jüni P, et al · · 2020 · cited 8× · PMID 32703515 · DOI 10.1016/j.jacc.2020.05.060