Xperience Pro PMCF Study

NCT ID: NCT05292144

Last Updated: 2023-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-26

Study Completion Date

2023-05-05

Brief Summary

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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 .

Detailed Description

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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.

Conditions

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Coronary Artery Disease (CAD) Ischemic Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary Artery Disease (CAD)

Xperience Pro

Intervention Type DEVICE

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

Interventions

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Xperience Pro

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient treated with Xperience pro according to routine hospital practice and following instructions for use
* Informed consent signed
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación EPIC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status

Hospital Universitario de Getafe

Getafe, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Site Status

Hospital Universitario Virgen de Valme

Seville, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 74678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21351225 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23369084 (View on PubMed)

Other Identifiers

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Xperience Pro PMCF Study

Identifier Type: -

Identifier Source: org_study_id

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