Coronary DiseaseCOMPLEXNCT06075602
COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLEX and Calcified Coronary Artery Disease
An observational study of Coronary Disease and Coronary Artery Disease, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- What is being tested?
- Impact of current PCI techniques/ devices in complex coronary artery lesions
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2021to 31 Dec 2031
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 11Show fewer
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Lucerne Heart Centre
Lucerne, Canton of Lucerne, 6000
Florim Cuculi, MD, +41412052154, florim.cuculi@luks.ch
About this study
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.
Read the 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.
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Coronary Arteriosclerosis, Coronary Artery Calcification, Stable Chronic Angina
- Being tested
- Impact of current PCI techniques/ devices in complex coronary artery lesions
- Medical subject headings
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Angina, Stable, Angina Pectoris, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of current PCI techniques/ devices in complex coronary artery lesionsDevice
To evaluate the impact of current PCI techniques/devices, but also CABG strategies, in patients with complex coronary artery lesions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Impact of current PCI techniques/ devices in complex coronary artery lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major adverse cardiac and cerebrovascular events (MACCE)
Measured: 1 year
Secondary outcomes (12)
Rate of combination of major adverse cardiac and cerebrovascular events (MACCE)
Measured: 1 year, 2 years, 5 years and 10 years
Rate of acute vessel closure
Measured: 1 year, 2 years, 5 years and 10 years
Rate of target vessel revascularization (TVR)
Measured: 1 year, 2 years, 5 years and 10 years
Rate of target lesion revascularization (TLR)
Measured: 1 year, 2 years, 5 years and 10 years
Rate of target lesion failure (TLF)
Measured: 1 year, 2 years, 5 years and 10 years
Rate of ischemia driven TLR
Measured: 1 year, 2 years, 5 years and 10 years
Rate of new AMI (NSTEMI/STEMI)
Measured: 1 year, 2 years, 5 years and 10 years
Rate of TIA or stroke
Measured: 1 year, 2 years, 5 years and 10 years
Rate of cardiovascular mortality
Measured: 1 year, 2 years, 5 years and 10 years
Rate of all-cause mortality
Measured: 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.
Measured: 1 year, 2 years, 5 years and 10 years
Rate of vascular complications (according to VARC criteria)
Measured: 1 year, 2 years, 5 years and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Nov 2021
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Bossard, Luzerner Kantonsspital
- Investigators
- Florim Cuculi, MD, Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075602
- Sponsor's protocol ID
- 2021-01290
- Acronym
- COMPLEX
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2023
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36085285Madanchi 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.
PubMed 34518287Pinilla-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.
PubMed 36907698Madanchi 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.
PubMed 33780431Bossard 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.
PubMed 35498044
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLEX and Calcified Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06075602
- Acronym / sponsor ID
- COMPLEX / 2021-01290
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Coronary Arteriosclerosis, Coronary Artery Calcification, Stable Chronic Angina
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Device: Impact of current PCI techniques/ devices in complex coronary artery lesionsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact of current PCI techniques/ devices in complex coronary artery lesionsTo evaluate the impact of current PCI techniques/devices, but also CABG strategies, in patients with complex coronary artery lesions | Device | Treatment |
Primary outcome
Rate of Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 1 year
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 36085285Seiler 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.
- Background: PubMed 34518287Madanchi 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.
- Background: PubMed 36907698Pinilla-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.
- Background: PubMed 33780431Madanchi 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.
- Background: PubMed 35498044Bossard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florim Cuculi, MD principal investigator
Luzerner Kantonsspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease and Coronary Artery Disease, run by Luzerner Kantonsspital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florim Cuculi, MD (+41412052154, florim.cuculi@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Major adverse cardiac and cerebrovascular events (MACCE) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06075602, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.