Coronary Artery Disease Clinical Trial
— COMPLEXOfficial title:
COMPLEX Registry - A Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting With compLEX and Calcified Coronary Artery Disease
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.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | December 31, 2031 |
Est. primary completion date | December 31, 2031 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: The presence of any one of the following exclusion criteria will lead to exclusion of the patient. - Patient is <18 years of age - Patient unwilling or unable to provide informed consent - Patients with no complex and calcified CAD |
Country | Name | City | State |
---|---|---|---|
Switzerland | Lucerne Heart Centre | Lucerne |
Lead Sponsor | Collaborator |
---|---|
Luzerner Kantonsspital |
Switzerland,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Major adverse cardiac and cerebrovascular events (MACCE) | 1 year | ||
Secondary | Rate of combination of major adverse cardiac and cerebrovascular events (MACCE) | 1 year, 2 years, 5 years and 10 years | ||
Secondary | Rate of acute vessel closure | 1 year, 2 years, 5 years and 10 years | ||
Secondary | Rate of target vessel revascularization (TVR) | 1 year, 2 years, 5 years and 10 years | ||
Secondary | Rate of target lesion revascularization (TLR) | 1 year, 2 years, 5 years and 10 years | ||
Secondary | Rate of target lesion failure (TLF) | 1 year, 2 years, 5 years and 10 years | ||
Secondary | Rate of ischemia driven TLR | 1 year, 2 years, 5 years and 10 years | ||
Secondary | Rate of new AMI (NSTEMI/STEMI) | 1 year, 2 years, 5 years and 10 years | ||
Secondary | Rate of TIA or stroke | 1 year, 2 years, 5 years and 10 years | ||
Secondary | Rate of cardiovascular mortality | 1 year, 2 years, 5 years and 10 years | ||
Secondary | Rate of all-cause mortality | 1 year, 2 years, 5 years and 10 years | ||
Secondary | Rate of bleeding events (access site or non-access site related) according to the BARC classification. | 1 year, 2 years, 5 years and 10 years | ||
Secondary | Rate of vascular complications (according to VARC criteria) | 1 year, 2 years, 5 years and 10 years |
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