CAPTURER PMCF Study ( rEPIC04D ) (rEPIC04D)

CAPTURER PMCF Post-Market Clinical Follow-up Study

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

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Disease; Coronary Artery Disease (CAD)
• Intervention / Treatment: Device: CAPTURER

Detailed 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 CAPTURER 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.

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Spain
  • Cadiz, Spain, 11009
    • H. Puerta Del Mar
  • Logroño, Spain, 26006
    • Hospital de San Pedro
  • Málaga, Spain, 29010
    • Hospital Universitario Regional de Malaga
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria
  • Santiago De Compostela, Spain, 15706
    • Hospital Clínico Universitario de Santiago de Compostela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with CAPTURER according to routine hospital practice and following instructions for use

Description

Inclusion Criteria:

• Patient treated with CAPTURER according to routine hospital practice and following instructions for use
• Informed consent signed

Exclusion Criteria:

• Not meet inclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coronary Artery Disease (CAD)	Device: CAPTURER; Patients in whom treatment with (CAPTURER) has been attempted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint. Freedom from Target Lesion Failure	Freedom from TARGET LESION FAILURE (TLF), composite end point of cardiac death, myocardial infarction, stroke and and new Target Lesion Revascularization (TLR)	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	30 days
Freedom from Device rupture	Freedom from Device rupture	During percutaneous coronary intervention (PCI)
Freedom from Kinking	Freedom from Kinking	During PCI
Freedom from Complicated withdrawal	Freedom from Complicated withdrawal	During PCI
Freedom from Coronary perforation	Freedom from Coronary perforation	During PCI
Freedom from Coronary dissection >C	Freedom from Coronary dissection >C	During PCI
Freedom from No reflow	Freedom from No reflow	During PCI
Freedom from Coronary thrombosis	Freedom from Coronary thrombosis	During PCI

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• 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.
• Chevalier B, Gilard M, Lang I, Commeau P, Roosen J, Hanssen M, Lefevre T, Carrie D, Bartorelli A, Montalescot G, Parikh K. Systematic primary aspiration in acute myocardial percutaneous intervention: a multicentre randomised controlled trial of the export aspiration catheter. EuroIntervention. 2008 Aug;4(2):222-8. doi: 10.4244/eijv4i2a40.
• Svilaas T, Vlaar PJ, van der Horst IC, Diercks GF, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Thrombus aspiration during primary percutaneous coronary intervention. N Engl J Med. 2008 Feb 7;358(6):557-67. doi: 10.1056/NEJMoa0706416.
• Sardella G, Mancone M, Bucciarelli-Ducci C, Agati L, Scardala R, Carbone I, Francone M, Di Roma A, Benedetti G, Conti G, Fedele F. Thrombus aspiration during primary percutaneous coronary intervention improves myocardial reperfusion and reduces infarct size: the EXPIRA (thrombectomy with export catheter in infarct-related artery during primary percutaneous coronary intervention) prospective, randomized trial. J Am Coll Cardiol. 2009 Jan 27;53(4):309-15. doi: 10.1016/j.jacc.2008.10.017.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2022
• Primary Completion (Actual): December 27, 2023
• Study Completion (Actual): December 27, 2023

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 23, 2022

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: MDR (Medical Device Regulations); PMCF (Post-Market Clinical Follow-up); Thrombus extraction catheter
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: CAPTURER PMCF Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No