COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLEX and Calcified Coronary Artery Disease

NCT06075602 | Recruiting

• 1 other identifier: 2021-01290
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the COMPLEX Registry is to prospectively and retrospectively collect baseline, clinical and procedural data of patients who have undergone PCI or CABG for complex and/ or calcified chronic CAD, irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. The outcomes will be compared in different clinical subgroups (e.g. PCI vs. CABG). The impact of current PCI techniques/ devices, but also CABG strategies in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Restenosis; Coronary Arteriosclerosis; Coronary Artery Calcification; Stable Chronic Angina; Angina Pectoris; Angina, Stable; Angina, Unstable; Stent Thrombosis

Outcome Measures

Primary Outcomes (1)

• Rate of Major adverse cardiac and cerebrovascular events (MACCE)

  1 year

Secondary Outcomes (12)

• Rate of combination of major adverse cardiac and cerebrovascular events (MACCE)

  1 year, 2 years, 5 years and 10 years

• Rate of acute vessel closure

  1 year, 2 years, 5 years and 10 years

• Rate of target vessel revascularization (TVR)

  1 year, 2 years, 5 years and 10 years

• Rate of target lesion revascularization (TLR)

  1 year, 2 years, 5 years and 10 years

• Rate of target lesion failure (TLF)

  1 year, 2 years, 5 years and 10 years

Study Arms (1)

Treatment

The project ́s main goal is to collect baseline, clinical and procedural data as well as to assess angiographic and clinical outcomes of patients with complex coronary lesions treated with current PCI techniques/ devices, but also CABG strategies in different clinical settings.

Device: Impact of current PCI techniques/ devices in complex coronary artery lesions

Interventions

Impact of current PCI techniques/ devices in complex coronary artery lesions DEVICE

To evaluate the impact of current PCI techniques/devices, but also CABG strategies, in patients with complex coronary artery lesions

Treatment

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

In an all-comers design, virtually any CAD patient with complex and/ or calcified coronary artery disease treated with PCI or CABG at the Heart Center of the Luzerner Kantonsspital (LUKS) and giving consent may be included.

You may qualify if:

• Subject \>18 years of age
• Individuals presenting with chronic, complex and/or calcified CAD and requiring PCI or CABG
• Complex coronary artery disease / lesions must include at least one of the following attributes:
• Long and/ or heavily calcified coronary lesions
• In-stent restenosis
• Chronic total occlusions (CTO)
• Left main lesions
• Bifurcation lesions
• Bypass graft lesions
• Small vessel disease / coronary microvascular dysfunction (e.g. not amenable to PCI)
• Subjects must be willing to sign a patient informed consent (PIC) or must have signed the General Consent (GK).

You may not qualify if:

• Patient is \<18 years of age
• Patient unwilling or unable to provide informed consent
• Patients with no complex and calcified CAD

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Sites (1)

Lucerne Heart Centre

Lucerne, Canton of Lucerne, 6000, Switzerland

RECRUITING

Related Publications (5)

• Seiler T, Attinger-Toller A, Cioffi GM, Madanchi M, Teufer M, Wolfrum M, Moccetti F, Toggweiler S, Kobza R, Bossard M, Cuculi F. Treatment of In-Stent Restenosis Using a Dedicated Super High-Pressure Balloon. Cardiovasc Revasc Med. 2023 Jan;46:29-35. doi: 10.1016/j.carrev.2022.08.018. Epub 2022 Aug 20.

  PMID: 36085285 BACKGROUND

• Madanchi M, Cioffi GM, Attinger-Toller A, Wolfrum M, Moccetti F, Seiler T, Vercelli L, Burkart P, Toggweiler S, Kobza R, Bossard M, Cuculi F. Long-term outcomes after treatment of in-stent restenosis using the Absorb everolimus-eluting bioresorbable scaffold. Open Heart. 2021 Sep;8(2):e001776. doi: 10.1136/openhrt-2021-001776.

  PMID: 34518287 BACKGROUND

• Pinilla-Echeverri N, Bossard M, Hillani A, Chavarria JA, Cioffi GM, Dutra G, Guerrero F, Madanchi M, Attinger A, Kossmann E, Sibbald M, Cuculi F, Sheth T. Treatment of Calcified Lesions Using a Dedicated Super-High Pressure Balloon: Multicenter Optical Coherence Tomography Registry. Cardiovasc Revasc Med. 2023 Jul;52:49-58. doi: 10.1016/j.carrev.2023.02.020. Epub 2023 Mar 2.

  PMID: 36907698 BACKGROUND

• Madanchi M, Cioffi GM, Kobza R, Cuculi F, Bossard M. The Importance of Defining the Coronary Anatomy in Suspected Myopericarditis: A Case Report. Am J Case Rep. 2021 Mar 29;22:e929009. doi: 10.12659/AJCR.929009.

  PMID: 33780431 BACKGROUND

• Bossard M, Madanchi M, Avdijaj D, Attinger-Toller A, Cioffi GM, Seiler T, Tersalvi G, Kobza R, Schupfer G, Cuculi F. Long-Term Outcomes After Implantation of Magnesium-Based Bioresorbable Scaffolds-Insights From an All-Comer Registry. Front Cardiovasc Med. 2022 Apr 14;9:856930. doi: 10.3389/fcvm.2022.856930. eCollection 2022.

  PMID: 35498044 BACKGROUND

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Restenosis; Angina, Stable; Angina Pectoris; Angina, Unstable

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Stenosis; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Florim Cuculi, MD

  Luzerner Kantonsspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florim Cuculi, MD

CONTACT

+41412052154; florim.cuculi@luks.ch

Matthias Bossard, MD

CONTACT

+41412051477; matthias.bossard@luks.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Co-Investigator

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: November 1, 2021
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

CH (1)