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Rise Semi Compliant Balloon Study in Patient With CAD

NCT04796038 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2023-01-25

No results posted yet for this study

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

Interventions

DEVICE

Balloon dilatation

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

Sponsors & Collaborators

  • Biosensors Europe SA

    lead INDUSTRY

Principal Investigators

  • Marco Roffi, Dr. · Hôpitaux universitaires de Genève (HUG)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2022-11-09
Completion
2022-11-09

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04796038 on ClinicalTrials.gov