NCT02377700

Brief Summary

Xeltis developed biodegradable patch prosthesis, the Vascular Patch Model COR-VP-001, to be used as a vascular patch to augment the pulmonary trunk and pulmonary arteries. The prosthesis is immediately mechanically functional, while its physiochemical characteristics should enable cell infiltration and tissue formation. The Xeltis Vascular Graft Model COR-VP-001 is specifically designed to improve surgical outcomes by reducing synthetic material related complications and improving hemodynamic characteristics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
3 months until next milestone

Results Posted

Study results publicly available

November 19, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

1.3 years

First QC Date

February 18, 2015

Results QC Date

September 24, 2020

Last Update Submit

November 16, 2020

Conditions

Heart Defects, Congenital

Outcome Measures

Primary Outcomes (1)

  • The Number of Patch Related Serious Adverse Events.

    Evaluation of the safety of the COR-VP-001 as defined by number of patients having patch related post-operative complications requiring surgery, intervention or leading to death up to 12 months post implantation

    12 months

Secondary Outcomes (2)

  • Number of Subjects With Loss of Functionality of the Patch.

    12 months

  • Histological Evaluation

    up to 12 Months after Implant

Study Arms (1)

Xeltis Vascular Patch, Model COR-VP-001

EXPERIMENTAL

Patients implanted with the vascular patch during staged bidirectional cava-pulmonary anastomosis.

Device: Xeltis Vascular Patch, Model COR-VP-001

Interventions

Xeltis Vascular Patch, Model COR-VP-001DEVICE

The intended use of the Xeltis Vascular Patch, Model COR-VP-001 is to augment pulmonary artery and thereby improve hemodynamics by increasing blood flow to the lungs in patients with congenital pulmonary artery obstructions as an initial part of the staged procedure of a bidirectional cava-pulmonary anastomosis

Xeltis Vascular Patch, Model COR-VP-001

Eligibility Criteria

Age2 Months - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patient requiring a bidirectional cava-pulmonary anastomosis
  • Male or Female
  • Age: 2 months to 16 years

You may not qualify if:

  • Other clinically significant malformations
  • Coagulation disorders as defined by INR outside its normal value, PTT \>ULN and Fibrinogen \<LLN and/or at the investigator's discretion
  • HIV-infection
  • Syphilis (Treponema pallidum)
  • Hepatitis-B and/or -C virus infection
  • Unwillingness of Parental/legal guardian to give consent
  • Treatment with other investigational products
  • Known or suspected noncompliance, drug or alcohol abuse of the parents/legal guardian
  • Inability of the parents/legal guardian to follow the procedures of the study, e.g. due to language problems
  • Participation of the patient in another study within 30 days preceding and during the present study
  • Previous enrolment of the patient into the current study
  • Enrolment of the investigator's family members, employees and other dependent persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakoulev Center for Cardiovascular Surgery

Moscow, 121552, Russia

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Eliane Schutte, CEO
Organization
Xeltis
clinical@xeltis.com
+31 40 751 7614

Study Officials

  • Leo Bockeria, Professor

    Bakoulev Center for Cardiovascular Surgery

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

February 18, 2015

First Posted

March 3, 2015

Study Start

June 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2020

Last Updated

November 19, 2020

Results First Posted

November 19, 2020

Record last verified: 2020-11

Locations

RU(1)