Rise Semi Compliant Balloon Study in Patient With CAD

NCT04796038 | Completed DMC

• 1 other identifier: 20-EU-02
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Percentage of treated lesions with device success defined as:

  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 Outcomes (3)

• Percentage of patients with Individual components of device success defined as:

  During the interventional procedure

• Percentage of patients with Procedural success defined as:

  1 - 7 Days

• Percentage of patients with Target Lesion Failure (TLF)

  1 - 7 Days

Study Arms (1)

Rise SC

EXPERIMENTAL

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

Device: Balloon dilatation

Interventions

Balloon dilatation DEVICE

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

Rise SC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Biosensors Europe SA: lead

Study Sites (3)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

HVS

Sion, Valis, 1950, Switzerland

Location

HUG

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Marco Roffi, Dr.

  Hôpitaux universitaires de Genève (HUG)

  PRINCIPAL INVESTIGATOR

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 10, 2021
• First Posted: March 12, 2021
• Study Start: January 31, 2022
• Primary Completion: November 9, 2022
• Study Completion: November 9, 2022
• Last Updated: January 25, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share

Locations

CH (3)