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Evaluation of the CIRCULATE Catheter for Transcoronary Administration of Pharmacologic and Cell-based Agents

NCT04703751 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-08-11

No results posted yet for this study

Summary

Clinical evaluation of the CIRCULATE catheter involves intracoronary administration of a typical medical agent (nitroglycerin) and a shown-to-be-safe cell-based agent (CardioCell) in patients with a diagnosis of dilated cardiomyopathy (DCM).

Conditions

  • Dilated Cardiomyopathy

Interventions

DEVICE

Transcoronary delivery of a pharmacological agent (nitroglycerin) and cell based agent (Cardiocell) using the CIRCULATE Catheter

Investigated device - the CIRCULATE Catheter will be introduced, using a standard radial or femoral access and a typical guiding catheter and typical coronary wire, first into the right coronary artery. After that the one dose of NTG (200µg) will be administered followed by a typical angiographic recording to visualize the vasodilatatory effect of the medication. Then CardioCell in doses of 10mln cells each (6.7mL) will be administered transcoronary to each of the coronary arteries (right coronary artery (RCA), LAD, left circumflex (Cx)). Angiography will be performed routinely before and after each product administration.

Sponsors & Collaborators

  • John Paul II Hospital, Krakow

    lead OTHER

Principal Investigators

  • Piotr Musialek, MD, DPhil · The John Paul II Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04703751 on ClinicalTrials.gov