NCT04121845: CrossRoad

CoROnary SinuS Reducer implantatiOn for ischemiA reDuction

Completed NA Last updated 25 July 2022

What this trial tests

NA trial testing Coronary Sinus Reducer device in Refractory Angina Pectoris in 25 participants. Completed in 30 June 2022.

Timeline

1 January 2019

Primary endpoint
31 December 2021

30 June 2022

Quick facts

Lead sponsor	University Medical Centre Ljubljana
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	25
Start date	1 January 2019
Primary completion	31 December 2021
Estimated completion	30 June 2022
Sites	1 location across Slovenia

Drugs / interventions tested

• Coronary Sinus Reducer device
• Sham procedure — full drug profile →

Conditions studied

• Refractory Angina Pectoris — all drugs for Refractory Angina Pectoris →

Sponsor

University Medical Centre Ljubljana

Who can join

Adults 18 to 85, any sex, with Refractory Angina Pectoris. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with refractory angina pectoris have low quality of life and reduced exertional capacity. Studies have shown that the coronary sinus reducer (CSR) implantation improves the quality of life. However, to date there are no firm objective data on improvement of exertional capacity. Studies have shown a large influence of placebo effect after interventional procedures, which is even more pronounced than in medically treated patients. As angina pectoris presents entirely subjective perception of chest discomfort, its improvement may be influenced by this effect in up to 30 %. The investigators will study weather the CSR implantation improves aerobic exertional capacity in comparison to optimal medical therapy alone. Further, the investigators will explore the extent of myocardial reversible ischemia reduction and possible influence on hrECG markers of left ventricular arrhythmogenicity. 40 patients with refractory angina CCS class (Canadian cardiovascular society) II-IV and confirmed reversible ischemia will be included. Patients will be randomized into two groups. The first group will undergo CSR implantation procedure. The second group will present a sham control group with placebo procedure. At inclusion and after 6 months the investigators will perform cardiopulmonary exercise test (CPET), single photon emission tomography for detection of reversible ischemia (SPECT), high resolution ECG (hrECG), echocardiography and asses the subjective burden of angina according to CCS score and the quality of life according to the Seattle angina Questionnaire (SAQ).

Publications & conference data

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

1. Effect of Coronary Sinus Reducer Implantation on Aerobic Exercise Capacity in Refractory Angina Patients-A CROSSROAD Study.
   Mrak M, Pavšič N, Žižek D, Ležaić L, et al · · 2023 · cited 5× · PMID 37367400 · DOI 10.3390/jcdd10060235
2. Son of a Lesser God: The Case of Cell Therapy for Refractory Angina.
   Bassetti B, Rurali E, Gambini E, Pompilio G. · · 2021 · cited 3× · PMID 34552966 · DOI 10.3389/fcvm.2021.709795
3. The Impact of Coronary Sinus Reducer on Arrhythmic Properties in Patients with Refractory Angina.
   Mrak M, Žlahtič T, Starc V, Ivanovski M, et al · · 2023 · cited 1× · PMID 39077099 · DOI 10.31083/j.rcm2412368
4. Coronary Sinus Reducing Stent for the Treatment of Refractory Angina Pectoris: A Health Technology Assessment.
   Stanak M, Rothschedl E, Szymanski P. · · 2020 · cited 1× · PMID 32982492 · DOI 10.2147/mder.s255440