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NCT05292144 Clinical Trial

Xperience Pro PMCF Study

Ischemic Heart Disease Clinical Trial

— rEPIC04A  

Official title:
Xperience Pro Post-Market Clinical Follow-up Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05292144
Other study ID # Xperience Pro PMCF Study
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 26, 2022
Est. completion date May 5, 2023

Study information
Verified date May 2023
Source Fundación EPIC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Xperience Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Xperience Pro .

Description:

The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Xperience Pro in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date May 5, 2023
Est. primary completion date April 26, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient treated with Xperience pro according to routine hospital practice and following instructions for use - Informed consent signed Exclusion Criteria: - Not meet inclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Xperience Pro
Patients in whom treatment with (Xperience Pro) has been attempted

Locations
Country Name City State
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Universitario de Getafe Getafe
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Marques de Valdecilla Santander
Spain Hospital Universitario Virgen de Valme Sevilla

Sponsors (1)
Lead Sponsor Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978 Feb 4;1(8058):263. doi: 10.1016/s0140-6736(78)90500-7. No abstract available. — View Citation

Kandzari DE, Teirstein PS, Kereiakes DJ, Cannon LA, Hearne SE, Kuo HC, Ying SW, Cheong WF, Popma JJ. Procedural effectiveness of a novel 1.20 mm diameter angioplasty catheter: clinical and angiographic outcomes. J Interv Cardiol. 2013 Apr;26(2):131-6. doi: 10.1111/j.1540-8183.2013.12021.x. Epub 2013 Jan 31. — View Citation

Kandzari DE, Zankar AA, Teirstein PS, Brilakis ES, Banerjee S, Price MJ, Stinis CT, Hudson PA, Dahle TG, Eng M, Brown R, Ferguson A, Addo TA, Popma JJ. Clinical outcomes following predilation with a novel 1.25-mm diameter angioplasty catheter. Catheter Cardiovasc Interv. 2011 Mar 1;77(4):510-4. doi: 10.1002/ccd.22734. Epub 2010 Nov 4. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Safety Endpoint. Freedom from Target Lesion Failure Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction and and new Target Lesion Revascularization (TLR) 7 days
Secondary Efficacy Endpoint. Freedom from Target Lesion Failure Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and and new Target Lesion Revascularization (TLR). 7 days
Secondary Freedom from Balloon rupture Freedom from Balloon rupture During percutaneous coronary intervention (PCI)
Secondary Freedom from Hypotube rupture Freedom from Hypotube rupture During PCI
Secondary Freedom from Complicated withdrawal Freedom from Complicated withdrawal During PCI
Secondary Freedom from Coronary perforation Freedom from Coronary perforation During PCI
Secondary Freedom from Coronary dissection >C Freedom from Coronary dissection >C During PCI
Secondary Freedom from No reflow Freedom from No reflow During PCI
Secondary Freedom from Coronary thrombosis Freedom from Coronary thrombosis During PCI
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