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

NCT04703751 | Unknown DMC

• 1 other identifier: CIRCULATE catheter evaluation
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Device success

  Device success, defined as the device introduction, administration of nitroglycerine and cell-based agent, and device removal without complications

  During procedure

Secondary Outcomes (2)

• Standardized uptake values (SUVs) of 99mTc-HMPAO radiolabelled CardioCell

  1 hour after application

• Freedom from major adverse cardiovascular events

  24 hours or until hospital discharge, whichever time point is first

Study Arms (1)

CIRCULATE Catheter

EXPERIMENTAL

CIRCULATE Catheter will be used to deliver nitroglycerin and CardioCell to evaluate safety and efficacy of the device

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

Interventions

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

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.

CIRCULATE Catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of DCM
• Left ventricular ejection fraction (LVEF) ≤ 45% by echocardiography
• Signed informed consent

You may not qualify if:

• Less than 3 months from any substantial cardiac therapeutic intervention (such as, e.g. CRT/ICD fitting)
• Less than 3 months from acute coronary syndrome
• BMI lower than 18 or greater than 45kg/m2
• Severe valvular heart disease or left ventricle aneurysm requiring aneurysmectomy or other structural interventions
• Present candidate for heart transplantation
• Active or any history of malignancy or tumor
• Moderate or severe immunodeficiency
• Chronic immunosuppressive therapy
• Acute or chronic infection
• Coagulopathies
• Known alcohol or drug dependence
• Severe renal dysfunction (eGFR\<20mL/min)
• Soft tissue disease or local infection in a place of required artery puncture
• Pregnancy or breastfeeding
• Females of childbearing potential who do not use a highly effective method of contraception, and in absence of a negative highly sensitive urine or serum pregnancy test

Sponsors & Collaborators

• John Paul II Hospital, Krakow: lead

Study Sites (1)

Department of Cardiac and Vascular Diseases, John Paul II Hospital

Krakow, Maloplska, 31-202, Poland

Location

Related Publications (8)

• Musialek P, Mazurek A, Jarocha D, Tekieli L, Szot W, Kostkiewicz M, Banys RP, Urbanczyk M, Kadzielski A, Trystula M, Kijowski J, Zmudka K, Podolec P, Majka M. Myocardial regeneration strategy using Wharton's jelly mesenchymal stem cells as an off-the-shelf 'unlimited' therapeutic agent: results from the Acute Myocardial Infarction First-in-Man Study. Postepy Kardiol Interwencyjnej. 2015;11(2):100-7. doi: 10.5114/pwki.2015.52282. Epub 2015 Jun 22.

  PMID: 26161101 BACKGROUND

• Musialek P, Tracz W, Skotnicki AB, Zmudka K, Pieniazek P, Walter Z, Szostek M, Majka M, Weglarska D, Zalewski J, Olszowska M, Kostkiewicz M, Pasowicz M, Klimeczek P, Przewlocki T. Transcoronary stem cell delivery using physiological endothelium-targeting perfusion technique: the rationale and a pilot study involving a comparison with conventional over-the-wire balloon coronary occlusions in patients after recent myocardial infarction. Kardiol Pol. 2006 May;64(5):489-98; discussion 499. English, Polish.

  PMID: 16752333 BACKGROUND

• Musialek P, Tekieli L, Kostkiewicz M, Miszalski-Jamka T, Klimeczek P, Mazur W, Szot W, Majka M, Banys RP, Jarocha D, Walter Z, Krupinski M, Pieniazek P, Olszowska M, Zmudka K, Pasowicz M, Kereiakes DJ, Tracz W, Podolec P, Wojakowski W. Infarct size determines myocardial uptake of CD34+ cells in the peri-infarct zone: results from a study of (99m)Tc-extametazime-labeled cell visualization integrated with cardiac magnetic resonance infarct imaging. Circ Cardiovasc Imaging. 2013 Mar 1;6(2):320-8. doi: 10.1161/CIRCIMAGING.112.979633. Epub 2012 Dec 27.

  PMID: 23271789 BACKGROUND

• Musialek P, Tekieli L, Kostkiewicz M, Majka M, Szot W, Walter Z, Zebzda A, Pieniazek P, Kadzielski A, Banys RP, Olszowska M, Pasowicz M, Zmudka K, Tracz W. Randomized transcoronary delivery of CD34(+) cells with perfusion versus stop-flow method in patients with recent myocardial infarction: Early cardiac retention of (9)(9)(m)Tc-labeled cells activity. J Nucl Cardiol. 2011 Feb;18(1):104-16. doi: 10.1007/s12350-010-9326-z. Epub 2010 Dec 14.

  PMID: 21161463 BACKGROUND

• Botti C, Negri DR, Seregni E, Ramakrishna V, Arienti F, Maffioli L, Lombardo C, Bogni A, Pascali C, Crippa F, Massaron S, Remonti F, Nerini-Molteni S, Canevari S, Bombardieri E. Comparison of three different methods for radiolabelling human activated T lymphocytes. Eur J Nucl Med. 1997 May;24(5):497-504. doi: 10.1007/BF01267680.

  PMID: 9142729 BACKGROUND

• Beeres SL, Bengel FM, Bartunek J, Atsma DE, Hill JM, Vanderheyden M, Penicka M, Schalij MJ, Wijns W, Bax JJ. Role of imaging in cardiac stem cell therapy. J Am Coll Cardiol. 2007 Mar 20;49(11):1137-48. doi: 10.1016/j.jacc.2006.10.072. Epub 2007 Mar 6.

  PMID: 17367656 BACKGROUND

• Chakravarty T, Henry TD, Kittleson M, Lima J, Siegel RJ, Slipczuk L, Pogoda JM, Smith RR, Malliaras K, Marban L, Ascheim DD, Marban E, Makkar RR. Allogeneic cardiosphere-derived cells for the treatment of heart failure with reduced ejection fraction: the Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells (DYNAMIC) trial. EuroIntervention. 2020 Jul 17;16(4):e293-e300. doi: 10.4244/EIJ-D-19-00035.

  PMID: 31763984 BACKGROUND

• Tseliou E, Kanazawa H, Dawkins J, Gallet R, Kreke M, Smith R, Middleton R, Valle J, Marban L, Kar S, Makkar R, Marban E. Widespread Myocardial Delivery of Heart-Derived Stem Cells by Nonocclusive Triple-Vessel Intracoronary Infusion in Porcine Ischemic Cardiomyopathy: Superior Attenuation of Adverse Remodeling Documented by Magnetic Resonance Imaging and Histology. PLoS One. 2016 Jan 19;11(1):e0144523. doi: 10.1371/journal.pone.0144523. eCollection 2016.

  PMID: 26784932 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Piotr Musialek, MD, DPhil

  The John Paul II Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Musialek, MD, DPhil

CONTACT

+48126142287; p.musialek@szpitaljp2.krakow.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical evaluation of the CIRCULATE catheter will be performed in a group of 10 patients. Each will receive intracoronary NTG followed by labelled CardioCell. This is a non-randomized study without any requirement for sample size calculation.

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 11, 2021
• Study Start: September 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)