ANGIOLITE PMCF Study ( rEPIC04F )

NCT05292014 | Completed DMC

• 1 other identifier: ANGIOLITE PMCF Study
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Coronary Artery Disease (CAD); Ischemic Heart Disease

Keywords

MDR (Medical Device Regulations); PMCF (Post-Market Clinical Follow-up); Drug Eluting Stent

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, stent thrombosis (Academic Research Consortium definitive/ probable), and new Target Lesion Revascularization (TLR)

  7 days

Secondary Outcomes (9)

• Efficacy Endpoint. Freedom fromTarget Lesion Failure

  7 days

• Freedom from Accidental dislodgement of the stent

  During percutaneous coronary intervention (PCI)

• Freedom from Balloon rupture

  During PCI

• Freedom from Hypotube rupture

  During PCI

• Freedom from Complicated withdrawal

  During PCI

Study Arms (1)

Coronary Artery Disease (CAD)

Device: ANGIOLITE

Interventions

ANGIOLITE DEVICE

Patients in whom treatment with ANGIOLITE has been attempted

Coronary Artery Disease (CAD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (6)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

H. Puerta Del Mar

Cadiz, 11009, Spain

Location

Hospital Universitario de Leon

León, 24080, Spain

Location

Hospital Universitario Virgen de La Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Related Publications (7)

• 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: 74678 BACKGROUND

• Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201.

  PMID: 2950322 BACKGROUND

• Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501. doi: 10.1056/NEJM199408253310802.

  PMID: 8041414 BACKGROUND

• Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.

  PMID: 8041413 BACKGROUND

• Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.

  PMID: 12050336 BACKGROUND

• Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, Colombo A, Schampaert E, Grube E, Kirtane AJ, Cutlip DE, Fahy M, Pocock SJ, Mehran R, Leon MB. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med. 2007 Mar 8;356(10):998-1008. doi: 10.1056/NEJMoa067193. Epub 2007 Feb 12.

  PMID: 17296824 BACKGROUND

• Wu X, Li L, He L. Drug-Coated Balloon versus Drug-Eluting Stent in Patients with Small-Vessel Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials. Cardiol Res Pract. 2021 Apr 13;2021:1647635. doi: 10.1155/2021/1647635. eCollection 2021.

  PMID: 33953973 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular 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 26, 2022
• Primary Completion: July 3, 2024
• Study Completion: August 3, 2024
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

ES (6)