IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction

NCT ID: NCT01226563

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-12-31

Brief Summary

The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for the prevention of ventricular remodeling and congestive heart failure when administered to subjects who had successful percutaneous coronary intervention with stent placement after ST segment elevation MI (STEMI).

Detailed Description

Heart failure is a significant problem, and carries substantial mortality. According to studies, left ventricular (LV) remodeling contributes independently to heart failure progression. Prevention and reversal of LV remodeling are correlated with decreased risk of death and heart failure events. IK-5001 is an implantable device to be used in subjects with recent myocardial infarction (MI). The IK-5001 device has been shown to directly halt the remodeling process that occurs following acute MI. IK-5001 replaces the damaged extracellular matrix (ECM) that has degraded during infarction, supports the damaged myocardial tissue, prevents local dyskinesis, and decreases wall stress. Because of its minimal interaction with the myocardium, its mechanism of action, its lack of specific pharmacologic activity and its elimination behavior, IK-5001 is a medical device in concurrence with the Global Harmonization Task Force's harmonized definition for medical devices.

Conditions

Acute Myocardial Infarction; Congestive Heart Failure; ST-Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

IK-5001

IK-5001 Sodium Alginate Calcium Gluconate intracoronary injection

Group Type: EXPERIMENTAL

IK-5001

Intervention Type: DEVICE

4 mL (+/- 0.2 mL) administered through intracoronary slow bolus injection over 15 to 30 seconds at least 2 days after PCI but within 5 days of onset of symptoms.

Saline Solution

Saline Solution intracoronary injection

Group Type: PLACEBO_COMPARATOR

Saline Solution

Intervention Type: DEVICE

4 mL (+/- 0.2 mL) slow bolus, intracoronary injection of saline solution will be administered over 15 to 30 seconds at least 2 days after percutaneous coronary intervention (PCI) but within 5 days of onset of symptoms.

Interventions

IK-5001

4 mL (+/- 0.2 mL) administered through intracoronary slow bolus injection over 15 to 30 seconds at least 2 days after PCI but within 5 days of onset of symptoms.

Intervention Type: DEVICE

Saline Solution

4 mL (+/- 0.2 mL) slow bolus, intracoronary injection of saline solution will be administered over 15 to 30 seconds at least 2 days after percutaneous coronary intervention (PCI) but within 5 days of onset of symptoms.

Intervention Type: DEVICE

Other Intervention Names

Sodium Alginate Calcium Gluconate; BIOABSORBABLE CARDIAC MATRIX (BCM)

Eligibility Criteria

Inclusion Criteria

1. The subject is ≥ 18 years of age.

2. The subject has given informed consent.

3. The subject has experienced a large STEMI defined by the following criteria:

Peak cardiac enzyme value within 48 hours of symptom onset as follows:

• Creatine kinase MB fraction (CK-MB) > 30 x the upper limit of normal OR
• Troponin I > 200 x upper limit of normal OR
• Troponin T > 60 x the upper limit of normal

AND at least 1 of the following 3 criteria:

• Delayed presentation with PCI > 6 hours from onset of symptoms
• Significant new Q waves in ≥ 2 anterior leads or anterior ST segment elevation of at least 3 mm persistent at 24 hours after PCI
• New onset of CHF (Killip class 3-4) or cardiogenic shock persistent at 24 hours after PCI

AND at least 1 of the following 2 criteria:

• MI ≥ 20% by Single Photon Emission Computed Tomography scan (SPECT) or cardiac Magnetic Resonance Imaging (MRI) with defect in the appropriate distribution
• Ejection fraction ≤ 35% with wall motion abnormality in the appropriate distribution at baseline imaging assessment

4. The subject has had successful PCI with stent within 48 hours of symptom onset, and residual stenosis less than 20% in the infarct related artery and greater than or equal to thrombolysis in myocardial infarction (TIMI) 2 flow. Subjects undergoing rescue PCI after thrombolysis or delayed presentation with ongoing ischemia may be enrolled.

5. For Germany only: Patients determined to have Killip class 4 at time of device deployment are not eligible for randomization.

Exclusion Criteria

1. Any subject with cardiogenic shock requiring mechanical ventilation or mechanical support at the time of deployment. Subject must be off mechanical support prior to deployment.

2. Need for urgent coronary artery bypass graft (CABG)

3. Clinically significant valvular heart disease with planned surgical correction or transcatheter aortic valve implantation (TAVI)

4. Uncontrolled ventricular arrhythmias

5. Renal insufficiency with a calculated creatinine clearance of less than 30 mL/ minute. See Appendix A for determining estimated creatinine clearance.

6. Clinically significant hepatic insufficiency

7. Inadequate imaging windows (defined as the inability to visualize the endocardial border of at least 16 of the 17 segments in both the apical four chambers and apical two chamber views without foreshortening) or arrhythmia that would preclude adequate 3D imaging on transthoracic echocardiography at the local baseline echo assessment

8. Non-ambulatory prior to the index MI

9. The subject has participated in another trial of an investigational agent within 30 days prior to randomization.

10. Subject has received resorbable stent as part of PCI.

11. The subject is pregnant or breastfeeding. Women of child-bearing potential will have a negative urine pregnancy test prior to randomization.

12. Any other concurrent condition that, in the opinion of the investigator, would prevent completion of the clinical trial, including inability to comply with follow up requirements.

13. For Germany only: In the investigator's opinion, the patient is not expected to survive ≥12 months.

14. For Germany only: 24 hours prior to device deployment, the patient has a serum calcium level greater than the upper limit of normal as determined by the local laboratory.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bellerophon BCM LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashika Ahmed, MD

Role: STUDY_DIRECTOR

Bellerophon Therapeutics

Locations

Cardiology, P.C.

Birmingham, Alabama, United States

Harbor - UCLA Medical Center

Torrance, California, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

University of Florida

Gainesville, Florida, United States

University of Miami Hospital

Miami, Florida, United States

St. Vincent Medical Group Inc.

Indianapolis, Indiana, United States

Henry Ford Health System

Detroit, Michigan, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Stony Brook Medicine

Stony Brook, New York, United States

Montefiore Medical Center Weiler Division

The Bronx, New York, United States

East Carolina Heart Institute - ECHI

Greenville, North Carolina, United States

Carl and Edyth Lindner Center for Research and Education @ Christ Hospital

Cincinnati, Ohio, United States

Ohio Health Research Institute

Columbus, Ohio, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Princess Alexandra Hospital

Woolloongabba, Brisbane, Australia

Gold Coast Hospital

Southport, Queensland, Australia

The Queen Elisabeth Hospital

Woodville South, South Australia, Australia

Alfred Hospital

Melbourne, Victoria, Australia

The Northern Hospital

Melbourne, Victoria, Australia

Flinders Medical Centre

Bedford Park, , Australia

Royal Perth Hospital - Dept. of Cardiology

Perth, , Australia

ZNA Middelheim

Antwerp, , Belgium

Universitair Ziekenhuis Brussel

Brussels, , Belgium

Ziekenhuis Oost-Limburg (ZOL)

Genk, , Belgium

CHU du Sart Tilman

Liège, , Belgium

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Queen Elizabeth II Health Science Centre

Halifax, Nova Scotia, Canada

York PCI Research

Newmarket, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Montreal Heart Institute

Montreal, , Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Québec, , Canada

Centre Hospitalier Universitaire de Sherbrooke

Québec, , Canada

Hopital de Brive Service de Cardiologie

Brive-la-Gaillarde, , France

Hopital Henri Mondor

Créteil, , France

Hopital du Bocage Central

Dijon, , France

CHU Grenoble - Hopital Michallon

Grenoble, , France

Centre Hospitalier Regional Universitaire de Lille

Lille, , France

Centre Hospitalier Universitaire de Nice Hopital Pasteur

Nice, , France

Hopital Lariboisiere

Paris, , France

Nouvel Hopital Civil

Strasbourg, , France

CHU de Toulouse - Hopital Rangueil

Toulouse, , France

Vivantes Netzwerk fur Gesundheit GmbH, Kinikum Neukolln

Berlin, , Germany

Vivantes Humboldt-Klinikum

Berlin, , Germany

Helios Klinikum Erfurt

Erfurt, , Germany

Elisabeth-Krankenhaus

Essen, , Germany

Universitatsklinikum Heidelberg

Heidelberg, , Germany

Universitatsklinikum Jena, Klinik fur Innere Medizin, Kardiologie

Jena, , Germany

Klinik fur Kardiologie and Angiologie Universitatsklinikum

Kiel, , Germany

University of Leipzig

Leipzig, , Germany

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, , Germany

Universitatsklinikum Schleswig-Holstein

Lübeck, , Germany

Universitatsmedizin Mannheim

Mannheim, , Germany

Klinikum der Universitat Munchen LMU

München, , Germany

Stadtische Kliniken Neuss - Lukaskrankenhaus

Neuss, , Germany

Klinikum Oldenburg gGmbH

Oldenburg, , Germany

St. Marien-Krankenhaus Siegen gem. GMbH

Siegen, , Germany

Krankenhaus Barmherzige Brüder Abt.Kardiologie und Pneumologie

Trier, , Germany

Helios Klinikum Wuppertal

Wuppertal, , Germany

The Edith Wolfson Medical Center

Holon, Tel Aviv, Israel

HaEmek Medical Center

Afula, , Israel

Barzilai Medical Center

Ashkelon, , Israel

Rambam Medical Center

Haifa, , Israel

The Lady Davis Carmel Medical Center

Haifa, , Israel

B'nai Zion Medical Center

Haifa, , Israel

Hadassah University Medical Center Jerusalem-Cardiology

Jerusalem, , Israel

Kaplan Medical Center

Rehovot, , Israel

Sheba Medical Center - Tel Hashomer

Tel Litwinsky, , Israel

UCK, Kliniczne Centrum Kardiologii

Gdansk, , Poland

Centrum Interwencyjnego Leczenia Chorob Serca i Naczyn z Pododdzialem Kardiologii Interwencyjnej

Krakow, , Poland

I Klinika Kardiologii i Elektrokardiologii lnterwencyjnej oraz Nadcisnienia Tetniczego CM UJ

Krakow, , Poland

Oddzial Kardiologiczny Wojewodzki Specjalistyczny Szpital im. Bieganskiego w Lodzi

Lodz, , Poland

Samodzileny Publiczny Szpital Kliniczny nr 4 w Lublinie

Lublin, , Poland

Samodzielny Publiczny Szpital Kliniczny nr 2 PUM w Szczecinie

Szczecin, , Poland

Pracownia Kardiologii Inwazyjnej

Warsaw, , Poland

Cetrainy Szpital Kliniczny MSWIA

Warsaw, , Poland

Hospital del Mar/Passeig Maritim 25-29

Barcelona, , Spain

Hospital Juan Ramon Jimenez

Huelva, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Clinico de Santiago de Compostela

Santiago, , Spain

Countries

United States; Australia; Belgium; Canada; France; Germany; Israel; Poland; Spain

References

Wei X, Chen S, Xie T, Chen H, Jin X, Yang J, Sahar S, Huang H, Zhu S, Liu N, Yu C, Zhu P, Wang W, Zhang W. An MMP-degradable and conductive hydrogel to stabilize HIF-1alpha for recovering cardiac functions. Theranostics. 2022 Jan 1;12(1):127-142. doi: 10.7150/thno.63481. eCollection 2022.

Reference Type: DERIVED

PMID: 34987638 (View on PubMed)

Rao SV, Zeymer U, Douglas PS, Al-Khalidi H, White JA, Liu J, Levy H, Guetta V, Gibson CM, Tanguay JF, Vermeersch P, Roncalli J, Kasprzak JD, Henry TD, Frey N, Kracoff O, Traverse JH, Chew DP, Lopez-Sendon J, Heyrman R, Krucoff MW. Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction. J Am Coll Cardiol. 2016 Aug 16;68(7):715-23. doi: 10.1016/j.jacc.2016.05.053.

Reference Type: DERIVED

PMID: 27515331 (View on PubMed)

Frey N, Linke A, Suselbeck T, Muller-Ehmsen J, Vermeersch P, Schoors D, Rosenberg M, Bea F, Tuvia S, Leor J. Intracoronary delivery of injectable bioabsorbable scaffold (IK-5001) to treat left ventricular remodeling after ST-elevation myocardial infarction: a first-in-man study. Circ Cardiovasc Interv. 2014 Dec;7(6):806-12. doi: 10.1161/CIRCINTERVENTIONS.114.001478. Epub 2014 Oct 28.

Reference Type: DERIVED

PMID: 25351198 (View on PubMed)

Other Identifiers

IK-5001-VENREM-201

Identifier Type: -

Identifier Source: org_study_id