IntelliStent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy

NCT06072937 | Not Yet Recruiting

• 1 other identifier: HPG-001-23
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pulmonary Arterial Hypertension; Dilated Cardiomyopathy; Congenital Heart Disease

Keywords

pediatric cardiology; pulmonary arterial hypertension; dilated cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Change in pulmonary vascular resistance (PVR)

  The primary efficacy endpoint is a binary variable. For patients with a baseline pulmonary vascular resistance (PVR) \>1000 dynes·s·cm-5, success is defined by an absolute reduction in PVR of ≥300 dynes·s·cm-5 at 24 weeks. For patients with a baseline PVR ≤1000 dynes·s·cm-5, success is a 30% reduction in PVR at 24 weeks.

  24 Weeks

Secondary Outcomes (6)

• Six Minute Walk Test Distance

  12 Weeks

• Change From Baseline to Week 12 in Borg Dyspnea Score

  Baseline to 12 weeks

• NYHA Class change from Baseline at Week 12

  Baseline to 12 weeks

• Change From Baseline to Week 12 in Ejection Fraction

  Baseline to 12 Weeks

• Change From Baseline to Week 12 in Left Ventricular Volumes

  Baseline to 12 Weeks

Study Arms (1)

IntelliStent Arm

EXPERIMENTAL

Single Arm Safety and Effectiveness of the IntelliStent System

Device: IntelliStent

Interventions

IntelliStent DEVICE

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.

IntelliStent Arm

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: Adolescent (12-17 years) or Adult (age \>18 years)
• 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
• Diagnosed with WHO Group 1 PH Classification pulmonary hypertension associated with congenital heart disease, evidence by the following parameters measured at rest:
• Mean pulmonary artery pressure (mPAP) ≥ 50 mmHg
• Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP)
• ≤ 15 mmHg.
• Pulmonary vascular resistance \> 3 Wood Units
• Patients with left ventricular dilated cardiomyopathy with symptoms despite optimal medical therapy
• Current WHO Functional Class III or IV.
• Patients with the following anatomical dimensions (gated CT with angio or MRI with EKG) at target implantation site:
• MPA diameter @ systolic ≥ 15 mm and ≤ 24 mm and length @ systolic ≥ 28 mm, or
• Left and Right PA Branch diameter @ systolic ≥ 15 mm and ≤ 24 mm and length @ systolic ≥ 28 mm
• 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.
• Each patient, or his or her guardian or legal representative, is willing to give informed consent, subject to national law.

You may not qualify if:

• Right ventricular dysfunction
• Severe AV valve regurgitation of the pulmonary ventricle
• Complex CHD
• Ongoing infection
• Patients where definitive correction of the CHD is indicated and available as a possible treatment option
• Patients with pressure gradient across the systemic outflow tract/subaortic region \>40 mmHg @ rest
• PAH-CHD patients with small defects that may be incidental findings
• PAH after corrective cardiac surgery
• Anatomical limitation to IntelliStent® (e.g. pulmonary artery size)
• Known or suspected thrombosis of the femoral or iliac veins on the proposed site of venous cannulation
• Vasculature lesions or characteristics that prevent percutaneous transluminal catheterization
• Allergies or contraindications to prescribed procedural medications and contrast medium Anomalous pulmonary venous return (total or partial)
• Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel
• Mental incapacity, unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with trial site personnel
• Pregnant, lactating or planning pregnancy

Sponsors & Collaborators

• HeartPoint Global: lead
• Meditrial USA Inc.: collaborator

Related Links

• Heartpoint Global
• Meditrial Clinical Research Organization

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Cardiomyopathy, Dilated; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cardiovascular Abnormalities; Congenital Abnormalities

Study Officials

• Monica Tocchi, MD, PhD

  Meditrial USA Inc. Clinical Research Organization

  STUDY DIRECTOR

Central Study Contacts

Monica Tocchi, MD, PhD

CONTACT

+1 646 933 1025; m.tocchi@meditrial.net

Study Design

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

Model Details: Single Arm Early Feasibility Trial

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: June 4, 2024
• Primary Completion: June 4, 2025
• Study Completion (Estimated): June 4, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Intention to publish date 09/01/2024
• Access Criteria: Available on request, Published as a supplement to the results publication.