Xperience Pro PMCF Study
rEPIC04A
Xperience Pro Post-Market Clinical Follow-up Study
1 other identifier
observational
46
1 country
5
Brief 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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2022
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2022
CompletedFirst Posted
Study publicly available on registry
March 23, 2022
CompletedStudy Start
First participant enrolled
October 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2023
CompletedMay 30, 2023
May 1, 2023
6 months
March 14, 2022
May 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Efficacy Endpoint. Freedom from Target Lesion Failure
7 days
Freedom from Balloon rupture
During percutaneous coronary intervention (PCI)
Freedom from Hypotube rupture
During PCI
Freedom from Complicated withdrawal
During PCI
Freedom from Coronary perforation
During PCI
- +3 more secondary outcomes
Study Arms (1)
Coronary Artery Disease (CAD)
Interventions
Patients in whom treatment with (Xperience Pro) has been attempted
Eligibility Criteria
Patients treated with Xperience pro according to routine hospital practice and following instructions for use
You may qualify if:
- Patient treated with Xperience pro according to routine hospital practice and following instructions for use
- Informed consent signed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundación EPIClead
Study Sites (5)
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario de Getafe
Getafe, 28905, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
Hospital Universitario Virgen de Valme
Seville, 41014, Spain
Related 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.
PMID: 74678BACKGROUNDKandzari 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.
PMID: 21351225BACKGROUNDKandzari 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.
PMID: 23369084BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2022
First Posted
March 23, 2022
Study Start
October 26, 2022
Primary Completion
April 26, 2023
Study Completion
May 5, 2023
Last Updated
May 30, 2023
Record last verified: 2023-05