COMPLEX Registry - A Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting With compLEX and Calcified Coronary Artery Disease

Sponsor

Luzerner Kantonsspital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06075602

Collaborator

(none)

5,000

Enrollment

Location

122

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease Coronary Artery Disease Coronary Restenosis Coronary Arteriosclerosis Coronary Artery Calcification Stable Chronic Angina Angina Pectoris Angina, Stable Angina, Unstable Stent Thrombosis	Device: Impact of current PCI techniques/ devices in complex coronary artery lesions

Detailed Description

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.
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.

PCI cohort:
To describe procedural and clinical performance of various PCI devices including high pressure balloons, scoring, balloons, cutting balloons, rotational atherectomy, orbital atherectomy, intravascular lithotripsy, stent and scaffold devices implanted in patients presenting with complex and calcified chronic CAD
To study the impact of different PCI devices and revascularization strategies used for lesion preparation and PCI optimization strategies among patients undergoing PCI
To describe early and late angiographic and OCT-findings among complex and calcified coronary artery disease patients treated with various metallic stent and scaffold devices
To assess possible predictors for coronary stent implantation or device failure 3. CABG cohort:

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 describe medical management (drugs regimens) as well as other lifestyle interventions in patients presenting with complex and calcified chronic CAD who are being treated with a primarily conservative (non-invasive) strategy.
To study the clinical impact of different treatment strategies/ medical regimens used among chronic, complex CAD, which are being managed solely with medical therapy.
To assess possible predictors for management failure (e.g. recurrence of symptoms or impaired quality of life).
To compare presentation, (medical) management, short- and long-term outcomes across the different treatment cohorts (PCI, CABG and medically managed cohort).
To specifically describe age- and gender-specific disparities across the various treatment regimens (e.g. PCI versus CABG).
To evaluate the impact of different antithrombotic regimens on patient's clinical outcomes 8. To study procedural and clinical outcomes among CAD patients requiring hemodynamic support using mechanical devices.
To analyze the performance of various non-invasive testing modalities (e.g. laboratory/ ECG parameters, treadmill-test, stress-echocardiography, CMR, SPECT or PET-CT) in order to predict outcomes of patients with chronic, complex CAD.
To describe economic implications (cost-effectiveness) of various interventional treatments for CAD.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

COMPLEX Registry - A Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting With compLEX and Calcified Coronary Artery Disease

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2031

Anticipated Study Completion Date :

Dec 31, 2031

Arms and Interventions

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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Rate of Major adverse cardiac and cerebrovascular events (MACCE) [1 year]

Secondary Outcome Measures

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]
Rate of ischemia driven TLR [1 year, 2 years, 5 years and 10 years]
Rate of new AMI (NSTEMI/STEMI) [1 year, 2 years, 5 years and 10 years]
Rate of TIA or stroke [1 year, 2 years, 5 years and 10 years]
Rate of cardiovascular mortality [1 year, 2 years, 5 years and 10 years]
Rate of all-cause mortality [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. [1 year, 2 years, 5 years and 10 years]
Rate of vascular complications (according to VARC criteria) [1 year, 2 years, 5 years and 10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).