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Rise Semi Compliant Balloon Study in Patient With CAD

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Balloon dilatation
Sponsored by
Biosensors Europe SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • General Inclusion Criteria

    1. Subject must be at least 18 years of age.
    2. Subject or a legally authorised representative must provide written informed consent prior to any study related procedure.
    3. Subject must have stenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention.
    4. Subject must agree to undergo all protocol-required follow-up procedures.
    5. Subject must agree not to participate in any other clinical study during hospitalisation for the index procedure.

  • Angiographic Inclusion Criteria All angiographic inclusion criteria are based on visual estimation.

    1. De novo or restenotic lesions in native coronary arteries or bypass grafts.
    2. A maximum of two lesions, with either both in one vessel or one lesion in each of two vessels.
    3. The target lesion(s) must have a diameter stenosis of ≥ 50% by visual estimation or online quantitative coronary angiography (QCA) and may include chronic total occlusions (CTO).

Exclusion Criteria:

  • General Exclusion Criteria

    1. Planned use of a non-study angioplasty balloon during the procedure for pre-dilatation or dilatation of the lesion.
    2. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, other anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-treated.
    3. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
    4. Subject is currently participating in an investigational study that may confound the treatment or outcomes of this study.
    5. Subject is pregnant or nursing. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

  • Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation.

    1. Unprotected left main coronary artery disease
    2. More than two lesions requiring treatment. Tandem lesions, defined as multiple, focal lesions that can be covered by one balloon, will be considered as a single lesion.
    3. Coronary artery spasm in the absence of significant stenosis.
    4. Anticipated need for plaque modification using rotational/orbital atherectomy or intravascular lithotripsy. Note: The use of scoring or cutting balloons after (pre)-dilatation with the study device is allowed.
    5. Additional clinically significant lesion(s) in any coronary arteries or bypass grafts for which PCI may be required during hospitalization for the index procedure (in-hospital staged PCI).

Sites / Locations

  • HVS
  • CHUV
  • HUG

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rise SC

Arm Description

All patients will receive the Rise semi-compliant balloon catheter as per treatment.

Outcomes

Primary Outcome Measures

Percentage of treated lesions with device success defined as:
Successful device delivery and Successful inflation and deflation of the balloon and No perforation, flow-limiting dissection or reduction in TIMI flow grade and No life-threatening arrhythmias (sustained Ventricular Tachycardia (VT), Ventricular Fibrillation (VF))

Secondary Outcome Measures

Percentage of patients with Individual components of device success defined as:
Successful device delivery Successful inflation and deflation of the balloon No perforation, flow-limiting dissection or reduction in TIMI flow grade No life-threatening arrhythmias (sustained VT, VF)
Percentage of patients with Procedural success defined as:
Device success without major adverse cardiovascular events (MACE) which is a composite of all death, myocardial infarction (MI), and clinically indicated target lesion revascularization (CI-TLR) by coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) during the index hospitalization.
Percentage of patients with Target Lesion Failure (TLF)
A composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR by CABG or PCI during the index hospitalization.

Full Information

First Posted
February 10, 2021
Last Updated
January 23, 2023
Sponsor
Biosensors Europe SA
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1. Study Identification

Unique Protocol Identification Number
NCT04796038
Brief Title
Rise Semi Compliant Balloon Study in Patient With CAD
Official Title
Evaluation of the Acute Safety and Device Success of the RISE SC Coronary Balloon Dilatation Catheter When Used as a Dilatation Device in the Stenotic Portion of a Coronary Artery or Bypass Graft in Patients With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
November 9, 2022 (Actual)
Study Completion Date
November 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosensors Europe SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Single arm, prospective, multi-center, trial designed to enrol approximately 66 patients. All patients will undergo PCI using at least one RISE SC balloon as per routine clinical practice and will be followed until discharge for data collection. Patients will be enrolled in up to 5 investigational sites in Switzerland. The patients will be followed up until discharge or until 7 days, whichever comes first.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rise SC
Arm Type
Experimental
Arm Description
All patients will receive the Rise semi-compliant balloon catheter as per treatment.
Intervention Type
Device
Intervention Name(s)
Balloon dilatation
Intervention Description
Patient will be treated with balloon dilatation either stand-alone (POBA) or followed by stent implantation.
Primary Outcome Measure Information:
Title
Percentage of treated lesions with device success defined as:
Description
Successful device delivery and Successful inflation and deflation of the balloon and No perforation, flow-limiting dissection or reduction in TIMI flow grade and No life-threatening arrhythmias (sustained Ventricular Tachycardia (VT), Ventricular Fibrillation (VF))
Time Frame
During the interventional procedure
Secondary Outcome Measure Information:
Title
Percentage of patients with Individual components of device success defined as:
Description
Successful device delivery Successful inflation and deflation of the balloon No perforation, flow-limiting dissection or reduction in TIMI flow grade No life-threatening arrhythmias (sustained VT, VF)
Time Frame
During the interventional procedure
Title
Percentage of patients with Procedural success defined as:
Description
Device success without major adverse cardiovascular events (MACE) which is a composite of all death, myocardial infarction (MI), and clinically indicated target lesion revascularization (CI-TLR) by coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) during the index hospitalization.
Time Frame
1 - 7 Days
Title
Percentage of patients with Target Lesion Failure (TLF)
Description
A composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR by CABG or PCI during the index hospitalization.
Time Frame
1 - 7 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: General Inclusion Criteria Subject must be at least 18 years of age. Subject or a legally authorised representative must provide written informed consent prior to any study related procedure. Subject must have stenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention. Subject must agree to undergo all protocol-required follow-up procedures. Subject must agree not to participate in any other clinical study during hospitalisation for the index procedure. Angiographic Inclusion Criteria All angiographic inclusion criteria are based on visual estimation. De novo or restenotic lesions in native coronary arteries or bypass grafts. A maximum of two lesions, with either both in one vessel or one lesion in each of two vessels. The target lesion(s) must have a diameter stenosis of ≥ 50% by visual estimation or online quantitative coronary angiography (QCA) and may include chronic total occlusions (CTO). Exclusion Criteria: General Exclusion Criteria Planned use of a non-study angioplasty balloon during the procedure for pre-dilatation or dilatation of the lesion. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, other anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-treated. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3. Subject is currently participating in an investigational study that may confound the treatment or outcomes of this study. Subject is pregnant or nursing. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test. Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation. Unprotected left main coronary artery disease More than two lesions requiring treatment. Tandem lesions, defined as multiple, focal lesions that can be covered by one balloon, will be considered as a single lesion. Coronary artery spasm in the absence of significant stenosis. Anticipated need for plaque modification using rotational/orbital atherectomy or intravascular lithotripsy. Note: The use of scoring or cutting balloons after (pre)-dilatation with the study device is allowed. Additional clinically significant lesion(s) in any coronary arteries or bypass grafts for which PCI may be required during hospitalization for the index procedure (in-hospital staged PCI).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Roffi, Dr.
Organizational Affiliation
Hôpitaux universitaires de Genève (HUG)
Official's Role
Principal Investigator
Facility Information:
Facility Name
HVS
City
Sion
State/Province
Valis
ZIP/Postal Code
1950
Country
Switzerland
Facility Name
CHUV
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
HUG
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The emphasis in all scientific publications and presentations will be placed on the endpoint at discharge.

Learn more about this trial

Rise Semi Compliant Balloon Study in Patient With CAD

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