IntelliStent Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy

Study Purpose

IntelliStent is intended to achieve reduction of pulmonary hypertension, improvements in symptoms and quality of life in adolescent and adult patients with congenital heart disease and dilated cardiomyopathy.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	12 Years - 60 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age: Adolescent (12-17 years) or Adult (age >18 years) 2. Uncorrected CHD (ASD, VSD, PDA, AVSD) with left to right + systemic pulmonary artery pressure or mixed shunting regardless if pulmonary vascular resistance is modifiable or fixed. 3. Eisenmenger or Pre-Eisenmenger syndrome, regardless if pulmonary vascular resistance is modifiable or fixed. 4. Diagnosed with WHO Group 1 PH Classification pulmonary hypertension associated with congenital heart disease, evidence by the following parameters measured at rest: 1. Mean pulmonary artery pressure (mPAP) ≥ 50 mmHg. 2. Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg. 3. Pulmonary vascular resistance > 3 Wood Units. 5. Reactive pulmonary vascular bed, defined as a reduction in mean PAP by 10 mmHg to < 40 mmHg (Sitbon Criteria) or as a decrease of mPAP or the mPAP/mean systemic arterial pressure (mSAP) ratio by ≥ 20% (Borst Criteria) using inhaled nitric oxide. 6. (Seemingly) fixed pulmonary vascular resistance, not modifiable with oxygen, NO or other medications. 7. Patients with the following anatomical dimensions (gated CT with angio or MRI with EKG) at target implantation site: 1. MPA diameter @ systolic ≥ 15 mm and ≤ 24 mm and length @ systolic ≥ 28 mm, or. 2. Left and Right PA Branch diameter @ systolic ≥ 15 mm and ≤ 24 mm and length @ systolic ≥ 28 mm. 8. Main pulmonary artery (MPA) or left/right PA Branch anatomy suitable for placement of the device as defined in the Instructions For Use (IFU) and as assessed by computed tomography (CT), fluoroscopy or echocardiography. 9. Current WHO Functional Class III or

IV. 10.

Each patient, or his or her guardian or legal representative, is willing to give informed consent, subject to national law.

Exclusion Criteria:

1. Complex CHD. 2. Anomalous pulmonary venous return (total or partial) 3. Aortic atresia. 4. Heterotaxy syndrome. 5. Ongoing infection. 6. Anatomical limitation to IntelliStent® (e.g., femoral vein impeded access, pulmonary artery size...) 7. Patients where definitive correction of the CHD is indicated and available as a possible treatment option and who have an acceptable risk of surgery. 8. Patients with single ventricle defects. 9. Patients with truncus arteriosus. 10. Patients with pressure gradient across the systemic outflow tract/subaortic region >40 mmHg @ rest. 11. PAH-CHD patients with small defects (ASD <2 cm) 12. PAH after corrective cardiac surgery. 13. Severe AV valve regurgitation of the pulmonary ventricle (or of the systemic AV valve in single ventricle patients) 14. Known or suspected thrombosis of the femoral or iliac veins on the proposed site of venous cannulation. 15. Allergies or contraindications to prescribed procedural medications and contrast medium. 16. Vasculature lesions or characteristics that prevent percutaneous transluminal catheterization. 17. Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel. 18. Mental incapacity, unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with trial site personnel. 19. Pregnant, lactating or planning pregnancy

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06072937
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	HeartPoint Global
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Monica Tocchi, MD, PhD
Principal Investigator Affiliation	Meditrial USA Inc. Clinical Research Organization
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Arterial Hypertension, Dilated Cardiomyopathy, Congenital Heart Disease
Study Website:	View Trial Website

Additional Details

IntelliStent Implant System is a kit of stents for adjustable interventional reduction of blood flow through a novel and minimally invasive intervention to replace surgical Pulmonary Artery Banding (PAB).

Arms & Interventions

Arms

Experimental: IntelliStent Arm

Single Arm Safety and Effectiveness of the IntelliStent System

Interventions

Device: - IntelliStent

Staged implantation of IntelliStent. The system comprises a nitinol self-expanding stent with a hollow element delivered over-the-wire into the main pulmonary artery or its left and right branches, using an 18 Fr transfemoral introducer sheath. The stent consists of two sections, one with a larger diameter and one with a smaller diameter, available in 6 sizes suitable for vessel sizes ranging from 20mm to 30 mm. Additional smaller sizes are currently under development.