NCT05292079

Brief Summary

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

5 active sites

Status
completed

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

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

September 29, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2023

Completed
Last Updated

November 22, 2024

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

March 14, 2022

Last Update Submit

November 21, 2024

Conditions

Coronary Artery Disease (CAD)Ischemic Heart Disease

Keywords

MDR (Medical Device Regulations)PMCF (Post-Market Clinical Follow-up)Thrombus extraction catheter

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Efficacy Endpoint. Freedom from Target Lesion Failure

    30 days

  • Freedom from Device rupture

    During percutaneous coronary intervention (PCI)

  • Freedom from Kinking

    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)

Device: CAPTURER

Interventions

CAPTURERDEVICE

Patients in whom treatment with (CAPTURER) has been attempted

Coronary Artery Disease (CAD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

H. Puerta Del Mar

Cadiz, 11009, Spain

Location

Hospital de San Pedro

Logroño, 26006, Spain

Location

Hospital Universitario Regional de Malaga

Málaga, 29010, Spain

Location

Hospital Universitario Virgen de La Victoria

Málaga, 29010, Spain

Location

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Related Publications (4)

  • 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: 74678BACKGROUND

  • 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.

    PMID: 19110787BACKGROUND

  • 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.

    PMID: 18256391BACKGROUND

  • 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.

    PMID: 19161878BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

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

September 29, 2022

Primary Completion

December 27, 2023

Study Completion

December 27, 2023

Last Updated

November 22, 2024

Record last verified: 2024-09

Locations

ES(5)