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

NCT ID: NCT06075602

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2031-12-31

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.

Detailed Description

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.

2. PCI cohort:

1. 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

2. To study the impact of different PCI devices and revascularization strategies used for lesion preparation and PCI optimization strategies among patients undergoing PCI

3. 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

4. To assess possible predictors for coronary stent implantation or device failure 3. CABG cohort:

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:

1. 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.

2. To study the clinical impact of different treatment strategies/ medical regimens used among chronic, complex CAD, which are being managed solely with medical therapy.

3. To assess possible predictors for management failure (e.g. recurrence of symptoms or impaired quality of life).

5. To compare presentation, (medical) management, short- and long-term outcomes across the different treatment cohorts (PCI, CABG and medically managed cohort).

6. To specifically describe age- and gender-specific disparities across the various treatment regimens (e.g. PCI versus CABG).

7. 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.

9. 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.

10. To describe economic implications (cost-effectiveness) of various interventional treatments for CAD.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

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

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Luzerner Kantonsspital

OTHER

Sponsor Role: lead

Responsible Party

Matthias Bossard

Principal Co-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Florim Cuculi, MD

Role: PRINCIPAL_INVESTIGATOR

Luzerner Kantonsspital

Locations

Lucerne Heart Centre

Lucerne, Canton of Lucerne, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Florim Cuculi, MD

Role: CONTACT

florim.cuculi@luks.ch

+41412052154

Matthias Bossard, MD

Role: CONTACT

matthias.bossard@luks.ch

+41412051477

Facility Contacts

Florim Cuculi, MD

Role: primary

florim.cuculi@luks.ch

+41412052154

References

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.

Reference Type: BACKGROUND

PMID: 36085285 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34518287 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36907698 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33780431 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35498044 (View on PubMed)

Other Identifiers

2021-01290

Identifier Type: -

Identifier Source: org_study_id