Rise Semi Compliant Balloon Study in Patient With CAD

January 23, 2023 updated by: Biosensors Europe SA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • HUG
    • Valis
      • Sion, Valis, Switzerland, 1950
        • HVS
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • CHUV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rise SC
All patients will receive the Rise semi-compliant balloon catheter as per treatment.
Device: Balloon dilatation
Patient will be treated with balloon dilatation either stand-alone (POBA) or followed by stent implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of treated lesions with device success defined as:
Time Frame: During the interventional procedure
  1. Successful device delivery and
  2. Successful inflation and deflation of the balloon and
  3. No perforation, flow-limiting dissection or reduction in TIMI flow grade and
  4. No life-threatening arrhythmias (sustained Ventricular Tachycardia (VT), Ventricular Fibrillation (VF))
During the interventional procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with Individual components of device success defined as:
Time Frame: During the interventional procedure
  1. Successful device delivery
  2. Successful inflation and deflation of the balloon
  3. No perforation, flow-limiting dissection or reduction in TIMI flow grade
  4. No life-threatening arrhythmias (sustained VT, VF)
During the interventional procedure
Percentage of patients with Procedural success defined as:
Time Frame: 1 - 7 Days
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.
1 - 7 Days
Percentage of patients with Target Lesion Failure (TLF)
Time Frame: 1 - 7 Days
A composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR by CABG or PCI during the index hospitalization.
1 - 7 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosensors Europe SA

Investigators

  • Principal Investigator: Marco Roffi, Dr., Hopitaux Universitaires de Geneve (HUG)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2022

Primary Completion (Actual)

November 9, 2022

Study Completion (Actual)

November 9, 2022

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-EU-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The emphasis in all scientific publications and presentations will be placed on the endpoint at discharge.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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