An observational study in Coronary Disease, Coronary Artery Disease and Coronary Restenosis, sponsored by Luzerner Kantonsspital. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-29.
Sponsored by Luzerner Kantonsspital · Observational
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.
a. PCI cohort - Periprocedural outcomes/ complications to be analyzed represent: final result (e.g. TIMI flow), stent expansion, dissections, perforations, and prevalence of thrombus (assessed by angiography and intravascular imaging) b. CABG cohort - Periprocedural outcomes/ complications to be analyzed include: final result (e.g. graft flow), number and type of grafts, total length of surgery, bypass time, cross-clamp time, median chest-tube output (mL), bleeding, duration of CCU/ ICU stay, re-operation.
c. For the PCI, CABG as well as medically managed cohort, short and long-term clinical outcomes of interest include: unstable angina (UA), stent-/scaffold thrombosis, target lesion failure (TLF), target vessel revascularization (TVR), ischemia driven revascularization, repeat hospitalization, new/worsening heart failure, cardiogenic shock, stroke, bleedings, cardiovascular death and all-cause death.
a. To describe procedural and clinical performance of various surgical techniques b. To assess outcomes across various surgical cohorts (e.g. urgent vs. elective, diabetic vs. non-diabetic, gender disparities) c. To investigate various CABG revascularization strategies (e.g. off- versus on-pump, "Fully arterial", minimal invasive approach) and their impact on short and long-term outcomes d. To describe perioperative recovery and risk for in-hospital complications (e.g. wound infections, pneumonia) e. To assess possible predictors for graft failure with contemporary surgical techniques 4. Conservative - only medically treated - cohort:
To assess possible predictors for management failure (e.g. recurrence of symptoms or impaired quality of life).
1,520 studies on the registry are indexed under Coronary Disease; 167 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 916 across 478 observational studies indexed under Coronary Disease.
Browse Coronary Disease studies →Luzerner Kantonsspital is the lead sponsor of 62 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The presence of any one of the following exclusion criteria will lead to exclusion of the patient.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
To evaluate the impact of current PCI techniques/devices, but also CABG strategies, in patients with complex coronary artery lesions
Rate of Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 1 year
Rate of combination of major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 1 year, 2 years, 5 years and 10 years
Rate of acute vessel closure
Time frame: 1 year, 2 years, 5 years and 10 years
Rate of target vessel revascularization (TVR)
Time frame: 1 year, 2 years, 5 years and 10 years
Rate of target lesion revascularization (TLR)
Time frame: 1 year, 2 years, 5 years and 10 years
Rate of target lesion failure (TLF)
Time frame: 1 year, 2 years, 5 years and 10 years
Rate of ischemia driven TLR
Time frame: 1 year, 2 years, 5 years and 10 years
Rate of new AMI (NSTEMI/STEMI)
Time frame: 1 year, 2 years, 5 years and 10 years
Rate of TIA or stroke
Time frame: 1 year, 2 years, 5 years and 10 years
Rate of cardiovascular mortality
Time frame: 1 year, 2 years, 5 years and 10 years
Rate of all-cause mortality
Time frame: 1 year, 2 years, 5 years and 10 years
Rate of bleeding events (access site or non-access site related) according to the BARC classification.
Time frame: 1 year, 2 years, 5 years and 10 years
Rate of vascular complications (according to VARC criteria)
Time frame: 1 year, 2 years, 5 years and 10 years
Started Nov 2021 (actual). Primary completion is estimated for Dec 2031, 121 months after the start.
Of 132 non-industry observational studies under Coronary Disease, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 192. This study's planned 121 months is above that.
Counting every sponsor, half of 154 studies reached it within 47 months; a quarter within 21 and three quarters within 123.
How these figures are worked out, and which studies are left out of them.
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Luzerner Kantonsspital