PCIShapeNCT07093788
Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions
A study testing super high-pressure balloon and intravascular lithotripsy (IVL) in people with PCI and Coronary Arterial Disease (CAD), run by Nanjing First Hospital, Nanjing Medical University at 3 sites in China.
Trial summary
this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PCI, Coronary Arterial Disease (CAD), Calcified Coronary Lesions
- What is being tested?
- super high-pressure balloon and intravascular lithotripsy (IVL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2025to 30 Jun 2027
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years and < 80 years
- Presented as asymptomatic angina, stable angina, unstable angina, prior myocardial infarction (MI), or non-ST-elevation myocardial infarction (NSTEMI).
- Have an indication for drug-eluting stent (DES) implantation
- Denovo coronary artery calcified lesions
- Target lesion diameter stenosis ≥ 70%, or target lesion diameter stenosis between ≥ 50% and < 70%, accompanied by evidence of myocardial ischemia(such as fractional flow reserve (FFR) ≤ 0.80 or minimal lumen area (MLA) ≤ 4.0 mm²).
- Reference vessel diameter of the target vessel between 2.5 mm - 4.5 mm
Show all 9Show fewer
- Maximum calcium arc within the lesion ≥ 270⁰ assessed by optical coherence tomography (OCT) or intravascular ultrasound (IVUS)
- Unsatisfactory lesion preparation with non-compliant balloon, defined as baseline diameter stenosis reduction of < 30% under maximal inflation pressure.
- Provision of written informed consent
Who cannot join
- Presented as acute ST-segment elevation myocardial infarction (STEMI), cardiogenic shock and multiple organ failure
- Presented as severe contrast agent allergy
- Intolerant to dual antiplatelet therapy (DAPT) and/or anticoagulation therapy
- Presented as active phase of autoimmune disease
- Calcified nodules or eccentric calcification lesions
- Failure to reach the target lesion with guidewires or catheters
- Complex coronary bifurcation lesions
- Target vessel thrombosis or aneurysm within 10 mm of the target lesion
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Lianyungang First People's Hospital
Lianyungang, Jiangsu, 222000
De-lu Yin, MD, 18961326475 ext. +86, druseyin@163.com
De-lu Yin, MD
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Fei Ye, MD, 18951670287 ext. +86, doctor_ye@126.com
Yi-fei Wang, MD, 18852577798 ext. +86, happywangyf2018@163.com
- Recruiting
Yixing People's Hospital
Yixing, Jiangsu, 214200
Liang Xu, MD, 18861576565 ext. +86, xl97010222@163.com
Peng-fei Wei, MD, 18761550965 ext. +86, weipengfei.1988@163.com
About this study
Official title: Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions: a Randomized Controlled Trial (Shape)
this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions
Read the detailed description
Calcified lesions posed a significant challenge in percutaneous coronary intervention (PCI). The existence of calcified plaque increased the difficulty of optimal stent expansion and the risk of target lesion failure(TLF). Consequently, optimizing the preparation techniques for calcified lesions before stent implantation has assumed growing importance.
As a kind of novel double-layered balloon, super high-pressure balloon can expand uniformly under extreme pressure. Previous studies have demonstrated that super high-pressure balloon perform non-inferiorly or superiorly to other strategies in terms of final stent expansion.
Through triggering localized pulsatile sonic pressure, intravascular lithotripsy(IVL) cracked intimal and medial calcium plaque within the artery. In present series of studies(DISRUPT), the optimized preparation of calcified lesions with IVL has been proved to be safe and effective. According to guidelines and clinical practice, IVL is applicable to different types of severe calcification lesions, including concentric and eccentric calcifications. However, considering its technological and economic costs, finding other preparation techniques non-inferiority to IVL was essential. In clinical practice, super high-pressure balloon had shown considerable effects of preparation for calcified lesions. However, study focused on the comparison of super high-pressure balloon with IVL for severe calcified lesions was limited.
In summary, this randomized trial aimed to evaluate the stent expansion through intravascular imaging among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions
- Being tested
- super high-pressure balloon, intravascular lithotripsy (IVL)
- Keywords
- super high-pressure balloon, percutaneous coronary intervention, intravascular lithotripsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
super high-pressure balloonDevice
preparation strategy for calcified lesions after unsatisfactory dilation
intravascular lithotripsy (IVL)Device
preparation strategy for calcified lesions after unsatisfactory dilation
| Study group | Role | What they receive |
|---|---|---|
| Super high-pressure balloon | Experimental | Patients underwent intravascular imaging -guided PCI were treated with super high-pressure balloon for lesion preparation. Receives: Device: super high-pressure balloon |
| Intravascular lithotripsy (IVL) | Experimental | Patients underwent intravascular imaging -guided PCI were treated with Intravascular lithotripsy (IVL) for lesion preparation. Receives: Device: intravascular lithotripsy (IVL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
stent expansion index
The stent expansion was associated with post-PCI clinical outcomes and the risk of stent failure.In this study, the primary endpoint was stent expansion index, which was defined as the final minimal luminal area (MLA) within the treated segment divided by the average reference vessel area assessed with intravascular imaging (optical coherence tomography(OCT)\&intravascular ultrasound(IVUS)).
Measured: Intraprocedural
Secondary outcomes (1)
30-days major adverse cardiac event (MACE)
The secondary endpoint was defined as the occurrence of major adverse cardiac events within 30 days, which was defined as a composite of cardiac death, target vessel-related myocardial infarction [TVMI] and clinically driven target vessel revascularisation[TVR].
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Sep 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PCIStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ye-fei, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Fei Ye, MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093788
- Sponsor's protocol ID
- KY20250425-03
- Acronym
- Shape
- Status last verified
- Mar 2026
- First submitted
- 10 Jul 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to privacy and ethical limitations, the data generated and analyzed in current study are not publicly available but could be obtained from principal investigator upon the approval of ethics committee
Publications
Cassese S, Simonetti F, Covarrubias HAA, Janisch M, Joner M, Kufner S, Lenz T, Pellegrini C, Rheude T, Sager H, Schunkert H, Starnecker F, Voll F, Xhepa E, Kastrati A, Kessler T. Intracoronary stenting and additional results achieved by shockWAVE coronary lithotripsy: design and rationale of ISAR-WAVE trial. Am Heart J. 2025 Apr;282:1-12. doi: 10.1016/j.ahj.2024.12.008. Epub 2024 Dec 20.
PubMed 39710352Sagris M, Ktenopoulos N, Dimitriadis K, Papanikolaou A, Tzoumas A, Terentes-Printzios D, Synetos A, Soulaidopoulos S, Lichtenberg M, Korosoglou G, Honton B, Tousoulis D, Tsioufis C, Toutouzas K. Efficacy of intravascular lithotripsy (IVL) in coronary stenosis with severe calcification: A multicenter systematic review and meta-analysis. Catheter Cardiovasc Interv. 2024 Apr;103(5):710-721. doi: 10.1002/ccd.31006. Epub 2024 Mar 14.
PubMed 38482928Rheude T, Rai H, Richardt G, Allali A, Abdel-Wahab M, Sulimov DS, Mashayekhi K, Ayoub M, Cuculi F, Bossard M, Kufner S, Xhepa E, Kastrati A, Fusaro M, Joner M, Byrne RA, Cassese S. Super high-pressure balloon versus scoring balloon to prepare severely calcified coronary lesions: the ISAR-CALC randomised trial. EuroIntervention. 2021 Aug 27;17(6):481-488. doi: 10.4244/EIJ-D-20-01000.
PubMed 33258774Rheude T, Fitzgerald S, Allali A, Mashayekhi K, Gori T, Cuculi F, Kufner S, Hemetsberger R, Sulimov DS, Rai H, Ayoub M, Bossard M, Xhepa E, Fusaro M, Toelg R, Joner M, Byrne RA, Richardt G, Kastrati A, Cassese S, Abdel-Wahab M. Rotational Atherectomy or Balloon-Based Techniques to Prepare Severely Calcified Coronary Lesions. JACC Cardiovasc Interv. 2022 Sep 26;15(18):1864-1874. doi: 10.1016/j.jcin.2022.07.034.
PubMed 36137691
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions: a Randomized Controlled Trial (Shape)
- ClinicalTrials.gov ID
- NCT07093788
- Acronym / sponsor ID
- Shape / KY20250425-03
- Keywords
- super high-pressure balloon, percutaneous coronary intervention, intravascular lithotripsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Jul 2025 (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.
this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions
Detailed description
Calcified lesions posed a significant challenge in percutaneous coronary intervention (PCI). The existence of calcified plaque increased the difficulty of optimal stent expansion and the risk of target lesion failure(TLF). Consequently, optimizing the preparation techniques for calcified lesions before stent implantation has assumed growing importance.
As a kind of novel double-layered balloon, super high-pressure balloon can expand uniformly under extreme pressure. Previous studies have demonstrated that super high-pressure balloon perform non-inferiorly or superiorly to other strategies in terms of final stent expansion.
Through triggering localized pulsatile sonic pressure, intravascular lithotripsy(IVL) cracked intimal and medial calcium plaque within the artery. In present series of studies(DISRUPT), the optimized preparation of calcified lesions with IVL has been proved to be safe and effective. According to guidelines and clinical practice, IVL is applicable to different types of severe calcification lesions, including concentric and eccentric calcifications. However, considering its technological and economic costs, finding other preparation techniques non-inferiority to IVL was essential. In clinical practice, super high-pressure balloon had shown considerable effects of preparation for calcified lesions. However, study focused on the comparison of super high-pressure balloon with IVL for severe calcified lesions was limited.
In summary, this randomized trial aimed to evaluate the stent expansion through intravascular imaging among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Super high-pressure balloon | Experimental | Device: super high-pressure balloonPatients underwent intravascular imaging -guided PCI were treated with super high-pressure balloon for lesion preparation. |
| Intravascular lithotripsy (IVL) | Experimental | Device: intravascular lithotripsy (IVL)Patients underwent intravascular imaging -guided PCI were treated with Intravascular lithotripsy (IVL) for lesion preparation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years and < 80 years
- Presented as asymptomatic angina, stable angina, unstable angina, prior myocardial infarction (MI), or non-ST-elevation myocardial infarction (NSTEMI).
- Have an indication for drug-eluting stent (DES) implantation
- Denovo coronary artery calcified lesions
- Target lesion diameter stenosis ≥ 70%, or target lesion diameter stenosis between ≥ 50% and < 70%, accompanied by evidence of myocardial ischemia(such as fractional flow reserve (FFR) ≤ 0.80 or minimal lumen area (MLA) ≤ 4.0 mm²).
Key exclusion criteria (8 listed)
- Presented as acute ST-segment elevation myocardial infarction (STEMI), cardiogenic shock and multiple organ failure
- Presented as severe contrast agent allergy
- Intolerant to dual antiplatelet therapy (DAPT) and/or anticoagulation therapy
- Presented as active phase of autoimmune disease
- Calcified nodules or eccentric calcification lesions
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 |
|---|---|---|
| super high-pressure balloonpreparation strategy for calcified lesions after unsatisfactory dilation | Device | Super high-pressure balloon |
| intravascular lithotripsy (IVL)preparation strategy for calcified lesions after unsatisfactory dilation | Device | Intravascular lithotripsy (IVL) |
Primary outcome
stent expansion index
Time frame: Intraprocedural
The stent expansion was associated with post-PCI clinical outcomes and the risk of stent failure.In this study, the primary endpoint was stent expansion index, which was defined as the final minimal luminal area (MLA) within the treated segment divided by the average reference vessel area assessed with intravascular imaging (optical coherence tomography(OCT)\&intravascular ultrasound(IVUS)).
1 secondary outcome
30-days major adverse cardiac event (MACE)
Time frame: 30 days
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 10 Mar 2026.
- Background: PubMed 39710352Cassese S, Simonetti F, Covarrubias HAA, Janisch M, Joner M, Kufner S, Lenz T, Pellegrini C, Rheude T, Sager H, Schunkert H, Starnecker F, Voll F, Xhepa E, Kastrati A, Kessler T. Intracoronary stenting and additional results achieved by shockWAVE coronary lithotripsy: design and rationale of ISAR-WAVE trial. Am Heart J. 2025 Apr;282:1-12. doi: 10.1016/j.ahj.2024.12.008. Epub 2024 Dec 20.
- Background: PubMed 38482928Sagris M, Ktenopoulos N, Dimitriadis K, Papanikolaou A, Tzoumas A, Terentes-Printzios D, Synetos A, Soulaidopoulos S, Lichtenberg M, Korosoglou G, Honton B, Tousoulis D, Tsioufis C, Toutouzas K. Efficacy of intravascular lithotripsy (IVL) in coronary stenosis with severe calcification: A multicenter systematic review and meta-analysis. Catheter Cardiovasc Interv. 2024 Apr;103(5):710-721. doi: 10.1002/ccd.31006. Epub 2024 Mar 14.
- Background: PubMed 33258774Rheude T, Rai H, Richardt G, Allali A, Abdel-Wahab M, Sulimov DS, Mashayekhi K, Ayoub M, Cuculi F, Bossard M, Kufner S, Xhepa E, Kastrati A, Fusaro M, Joner M, Byrne RA, Cassese S. Super high-pressure balloon versus scoring balloon to prepare severely calcified coronary lesions: the ISAR-CALC randomised trial. EuroIntervention. 2021 Aug 27;17(6):481-488. doi: 10.4244/EIJ-D-20-01000.
- Background: PubMed 36137691Rheude T, Fitzgerald S, Allali A, Mashayekhi K, Gori T, Cuculi F, Kufner S, Hemetsberger R, Sulimov DS, Rai H, Ayoub M, Bossard M, Xhepa E, Fusaro M, Toelg R, Joner M, Byrne RA, Richardt G, Kastrati A, Cassese S, Abdel-Wahab M. Rotational Atherectomy or Balloon-Based Techniques to Prepare Severely Calcified Coronary Lesions. JACC Cardiovasc Interv. 2022 Sep 26;15(18):1864-1874. doi: 10.1016/j.jcin.2022.07.034.
- Individual participant dataSharing planned: No. Due to privacy and ethical limitations, the data generated and analyzed in current study are not publicly available but could be obtained from principal investigator upon the approval of ethics committee
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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.
Fei Ye, MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing super high-pressure balloon and intravascular lithotripsy (IVL) in people with PCI and Coronary Arterial Disease (CAD), run by Nanjing First Hospital, Nanjing Medical University at 3 sites in China.
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 9 inclusion and 8 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 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 Fei Ye, MD (18951670287 ext. +86, doctor_ye@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stent expansion index (time frame: Intraprocedural). 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 NCT07093788, which also lists 4 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 10 Mar 2026.