Rise Semi Compliant Balloon Study in Patient With CAD

NCT ID: NCT04796038

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2022-11-09

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rise SC

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

Group Type: EXPERIMENTAL

Balloon dilatation

Intervention Type: DEVICE

Patient will be treated with balloon dilatation either stand-alone (POBA) or followed by stent implantation.

Interventions

Balloon dilatation

Patient will be treated with balloon dilatation either stand-alone (POBA) or followed by stent implantation.

Intervention Type: DEVICE

Eligibility Criteria

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.

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

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.

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosensors Europe SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Roffi, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux universitaires de Genève (HUG)

Locations

CHUV

Lausanne, Canton of Vaud, Switzerland

HVS

Sion, Valis, Switzerland

HUG

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

20-EU-02

Identifier Type: -

Identifier Source: org_study_id