Coronary Artery DiseaseHYPER IINCT05650450

Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease

An observational study of Coronary Artery Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

An observational study to evaluate safety and efficacy of the hybrid approach DES/DCB in the treatment of long diffuse de novo coronary artery disease Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Coronary Artery Disease
What is being tested?: DES+DCB
Type of treatment: Medical device
How many people: 500 participants
Where: 1 siteItaly
Study dates: 1 May 2022to 1 Jan 2025
How long will I take part?: 12 Months
Phase: Observational
Are there results?: None posted in the registry

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 to 100 years
All sexes
Adult, Older adult

Study population: Patients presenting with stable or unstable CAD eligible for PCI (according to the international guidelines) because of diffuse long (>38 mm) CAD involving contiguous segments of the same vessel suitable for a hybrid approach (RVD>2.75 mm in the proximal DES target segment and RVD ≤2.75 mm ≥ 2.0 mm for the distal DCB target segment). Hybrid approach is defined as overlapping or slightly (2-3 mm) superimposing a new generation DES in the larger, more proximal part of the vessel -reference vessel diameter -RVD >2.75 mm- and DCB inflation for a concomitant and contiguous de novo small vessel disease - distally located with RVD ≤2.75 mm ≥2.0 mm.

Who may be able to join

Patients presenting with stable or unstable CAD eligible for PCI (according to the international guidelines) because of diffuse long (>38 mm) CAD involving contiguous segments of the same vessel suitable for a hybrid approach (RVD>2.75 mm in the proximal DES target segment and RVD ≤2.75 mm ≥ 2.0 mm for the distal DCB target segment);
Signed Patient Informed Consent/Data Release Form

Who cannot join

Age <18 years;
Cardiogenic shock;
Pregnancy or breastfeeding;
Target vessel reference diameter (within planned device deployment segments) <2.0 or >5.0 mm;
Comorbidities with life expectancy <12 months
Severe calcification or/tortuosity proximally or at the DCB target segment;
Prior PCI and stent implantation in the target vessel.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Istituto Clinico S.Ambrogio
Milan

Other trials in Italy

About this study

Official title: A Hybrid Approach Evaluating A Drug-Coated Balloon in Combination With A New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease: The HYPER II Study

An observational study to evaluate safety and efficacy of the hybrid approach DES/DCB in the treatment of long diffuse de novo coronary artery disease

Read the detailed description

This is a prospective, non-randomized, single-arm, multi-center study aiming to assess the feasibility and the clinical outcomes of using the Restore DCB (Cardionovum GmbH, Bonn, Germany) in combination ("hybrid approach") with a new generation DES (type at operator's discretion) for the treatment of diffuse CAD (Coronary Artery Disease) encountered in daily clinical practice (lesion length > 38 mm). The rationale of the proposed strategy derives from the characteristics of DCB in treating the atherosclerotic disease without leaving a permanent structure in the vessel especially in case of diffuse CAD -avoiding a long metallic, permanent cage within extended coronary segments

Conditions: Coronary Artery Disease
Being tested: DES+DCB
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DES+DCBDevice
Hybrid approach is defined as overlapping or slightly (2-3 mm) superimposing a new generation DES for a de novo long (>38 mm) lesion (located in the larger, more proximal part of the vessel -reference vessel diameter -RVD >2.75 mm-) and DCB inflation for a concomitant and contiguous de novo small vessel disease (distally located with RVD ≤2.75 mm ≥ 2.0 mm)

Study groups in NCT05650450
Study group	Role	What they receive
Patient with diffuse CAD disease treated with hybrid strategy (DES+DCB)		Not described Receives: Device: DES+DCB

What is being measured

The primary outcome is the main question the study is designed to answer.

TLF in DES/DCB treated segment at 12 months
Target lesion failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) in the DES- and/or the drug-coated balloon (DCB)-treated segment within 12 months after the index procedure
Measured: 12 months

Secondary outcomes (5)

Procedural success
Procedural success defined as both DCB/DES delivery and implantation at the "target" lesion site with <30% diameter stenosis (DS) in the DCB-treated segment and <10% DS in the DES-treated segment and distal TIMI (Thrombolysis in Myocardial Infarction) 3 flow
Measured: At procedure
Peri-procedural myocardial infarction
Peri-procedural myocardial infarction defined as an elevation of cardiac biomarkers (troponin or creatine kinase-myocardial band) >3 times the upper limit of normal
Measured: Pre-discharge
TLF
TLF and its singular components (cardiac death, any TV-MI excluding peri-procedural MI, ID-TLR)
Measured: Pre-discharge, 30 days, 12 months, 24 months
Thrombosis
Any definite/probable DES- or DCB-treated segment thrombosis
Measured: In-hospital (within 7 days after PCI), at 30-days, 12 months, 24 months follow-up
Flow-limiting dissection
low-limiting dissection (type C-F waiting 3 minutes after DCB inflation) requiring additional DES implantation in the DCB-treated segment
Measured: At procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20221 Jan 2025

First posted14 Dec 2022
Study start1 May 2022
Primary completion1 Jan 2025 (estimated)
Study completion1 Jan 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
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: 500 participants (estimated)
Target duration: 12 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT05650450
Sponsor's protocol ID: HYPER II
Acronym: HYPER II
Status last verified: Jan 2024
First submitted: 4 Dec 2022
Last updated: 8 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Ielasi A, Buono A, Pellicano M, Tedeschi D, Loffi M, Donahue M, Regazzoli D, De Angelis G, Danzi G, Reimers B, Tespili M. A HYbrid APproach Evaluating a DRug-Coated Balloon in Combination With a New-Generation Drug-Eluting Stent in the Treatment of De Novo Diffuse Coronary Artery Disease: The HYPER Pilot Study. Cardiovasc Revasc Med. 2021 Jul;28:14-19. doi: 10.1016/j.carrev.2020.07.036. Epub 2020 Jul 31.
PubMed 32933874
Ielasi A, Miyazaki T, Geraci S, Testa L, Abdel-Wahab M, Kawamoto H, Ruparelia N, Sato T, Caramanno G, Bedogni F, Tespili M, Colombo A, Latib A. Hybrid strategy with a bioresorbable scaffold and a drug-coated balloon for diffuse coronary artery disease: the "no more metallic cages" multicentre pilot experience. EuroIntervention. 2016 Apr 8;11(14):e1589-95. doi: 10.4244/EIJV11I14A309.
PubMed 27056119

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Hybrid Approach Evaluating A Drug-Coated Balloon in Combination With A New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease: The HYPER II Study
ClinicalTrials.gov ID: NCT05650450
Acronym / sponsor ID: HYPER II / HYPER II
Conditions: Coronary Artery Disease
Study type: Observational
Recruitment status: Unknown status
Enrolment: 500 participants (estimated)
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
Study start: 1 May 2022 (actual)
Primary completion: 1 Jan 2025 (estimated)
Study completion: 1 Jan 2025 (estimated)
First posted: 14 Dec 2022 (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.

An observational study to evaluate safety and efficacy of the hybrid approach DES/DCB in the treatment of long diffuse de novo coronary artery disease

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 12 Months
Number of arms: 1

Arm	Type	Receives
Patient with diffuse CAD disease treated with hybrid strategy (DES+DCB)	–	Device: DES+DCB

Who may qualify

Ages: 18 to 100 years
Sex: All
Age groups: Adult, Older adult
Study population: Patients presenting with stable or unstable CAD eligible for PCI (according to the international guidelines) because of diffuse long (>38 mm) CAD involving contiguous segments of the same vessel suitable for a hybrid approach (RVD>2.75 mm in the proximal DES target segment and RVD ≤2.75 mm ≥ 2.0 mm for the distal DCB target segment). Hybrid approach is defined as overlapping or slightly (2-3 mm) superimposing a new generation DES in the larger, more proximal part of the vessel -reference vessel diameter -RVD >2.75 mm- and DCB inflation for a concomitant and contiguous de novo small vessel disease - distally located with RVD ≤2.75 mm ≥2.0 mm.

Key inclusion criteria (2 listed)

Patients presenting with stable or unstable CAD eligible for PCI (according to the international guidelines) because of diffuse long (>38 mm) CAD involving contiguous segments of the same vessel suitable for a hybrid approach (RVD>2.75 mm in the proximal DES target segment and RVD ≤2.75 mm ≥ 2.0 mm for the distal DCB target segment);
Signed Patient Informed Consent/Data Release Form

Key exclusion criteria (7 listed)

Age <18 years;
Cardiogenic shock;
Pregnancy or breastfeeding;
Target vessel reference diameter (within planned device deployment segments) <2.0 or >5.0 mm;
Comorbidities with life expectancy <12 months

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
DES+DCBHybrid approach is defined as overlapping or slightly (2-3 mm) superimposing a new generation DES for a de novo long (>38 mm) lesion (located in the larger, more proximal part of the vessel -reference vessel diameter -RVD >2.75 mm-) and DCB inflation for a concomitant and contiguous de novo small vessel disease (distally located with RVD ≤2.75 mm ≥ 2.0 mm)	Device	Patient with diffuse CAD disease treated with hybrid strategy (DES+DCB)

Primary outcome

TLF in DES/DCB treated segment at 12 months
Time frame: 12 months
Target lesion failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) in the DES- and/or the drug-coated balloon (DCB)-treated segment within 12 months after the index procedure

5 secondary outcomes

Procedural success
Time frame: At procedure
Peri-procedural myocardial infarction
Time frame: Pre-discharge
TLF
Time frame: Pre-discharge, 30 days, 12 months, 24 months
Thrombosis
Time frame: In-hospital (within 7 days after PCI), at 30-days, 12 months, 24 months follow-up
Flow-limiting dissection
Time frame: At procedure

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
Background: PubMed 32933874Ielasi A, Buono A, Pellicano M, Tedeschi D, Loffi M, Donahue M, Regazzoli D, De Angelis G, Danzi G, Reimers B, Tespili M. A HYbrid APproach Evaluating a DRug-Coated Balloon in Combination With a New-Generation Drug-Eluting Stent in the Treatment of De Novo Diffuse Coronary Artery Disease: The HYPER Pilot Study. Cardiovasc Revasc Med. 2021 Jul;28:14-19. doi: 10.1016/j.carrev.2020.07.036. Epub 2020 Jul 31.
Background: PubMed 27056119Ielasi A, Miyazaki T, Geraci S, Testa L, Abdel-Wahab M, Kawamoto H, Ruparelia N, Sato T, Caramanno G, Bedogni F, Tespili M, Colombo A, Latib A. Hybrid strategy with a bioresorbable scaffold and a drug-coated balloon for diffuse coronary artery disease: the "no more metallic cages" multicentre pilot experience. EuroIntervention. 2016 Apr 8;11(14):e1589-95. doi: 10.4244/EIJV11I14A309.

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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 Artery Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.

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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Feb 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 Italy. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TLF in DES/DCB treated segment at 12 months (time frame: 12 months). 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 NCT05650450, which also lists 2 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 8 Feb 2024.