Rise Semi Compliant Balloon Study in Patient With CAD

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Balloon dilatation

• Registration Number: NCT04796038
• Lead Sponsor: Biosensors Europe SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-12
• Study Start: 2022-01-31
• Status Verified: 2022-06
• Primary Completion: 2022-11-09
• Study Completion: 2022-11-09
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rise SC	Balloon dilatation	All patients will receive the Rise semi-compliant balloon catheter as per treatment.

Primary Outcome Measures

Name	Time	Method
Percentage of treated lesions with device success defined as:	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))

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with Individual components of device success defined as:	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)
Percentage of patients with Procedural success defined as:	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.
Percentage of patients with Target Lesion Failure (TLF)	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.

Trial Locations

Locations (3)

HVS; 🇨🇭 Sion, Valis, Switzerland

CHUV; 🇨🇭 Lausanne, Vaud, Switzerland

HUG; 🇨🇭 Geneva, Switzerland