Coronary Artery DiseasePOT-DESNCT05368129
Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After DES Implantation
A study testing Balloon dilation in people with Coronary Artery Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The objective of this randomized control trial is to gain clinical insight on the use of POT PTCA balloon dilatation catheter for the optimal dilation after drug-eluting stent implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Balloon dilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2022to 30 Dec 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures;
- Men and women 18 years and older;
- Patients with asymptomatic myocardial ischemia, stable or unstable angina, or acute myocardial infarction with symptoms lasting more than 12 hours;
- The target lesions was de novo lesion;
- Reference vessel diameter of target lesion is between 2.25-4.0mm, and the lesion length is less than 15mm(visual inspection);
- Diameter stenosis of target lesion diameter ≥70% or ≥50%(visual) with ischemia evidence;
- DES was successfully implanted in target lesions;
- TIMI 3 blood flow of target vessel before post-dilation.
Who cannot join
- Subjects had clinical symptoms and/or ECG changes consistent with ST-elevation myocardial infarction within 12 hours;
- Allergies to concomitant medications required by the balloon/stent system or protocol used in the study;
- Cannot tolerate dual antiplatelet therapy;
- Life expectancy is less than 6 months;
- Pregnant or lactating women;
- Participating in another clinical trial and has not completed the primary endpoint observation of the trial;
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- Planned multiple operations, failed to follow the treatment prescribed in the protocol or affected data analysis and interpretation;
- Restenosis disease;
- Target lesions with severe calcification require rotary grinding treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After Drug-eluting Stent Implantation: a Prospective, Multicenter, Randomized Controlled Clinical Trial
The objective of this randomized control trial is to gain clinical insight on the use of POT PTCA balloon dilatation catheter for the optimal dilation after drug-eluting stent implantation.
Read the detailed description
The current study is designed as a multicenter, randomized and prospective study aiming to compare the change in minimal stent area (MLA) of POT PTCA balloon dilatation catheter on patients with drug-eluting stent (DES) implantation. Based on the previous studies, the MLA in the proximal and distal 3mm segments was 7.38 mm^2 and 8.08 mm^2 before non-compliant balloon (NCB) dilation, respectively. After NCB dilation, that MSA in the proximal and distal 3mm segments was 7.53mm^2 and 9.55mm^2, respectively. As a result, a total of 48 patients with DES implantation are randomized at a ratio of 1:1 to either POT PTCA balloon dilatation catheter group (POT group) or Quantum Maverick balloon catheter group (NCB group) using a randomization schedule blocked by site.
- Conditions
- Coronary Artery Disease
- Being tested
- Balloon dilation
- 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.
Balloon dilationProcedure or surgery
Balloon dilation was performed after DES implantation.
| Study group | Role | What they receive |
|---|---|---|
| POT group | Experimental | A total of 24 patients are assigned to POT group after randomization schedule. Receives: Procedure: Balloon dilation |
| NCB group | Active comparator | A total of 24 patients are assigned to NCB group after randomization schedule. Receives: Procedure: Balloon dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal stent area
The change of minimum stent area measured by intravascular ultrasound.
Measured: through PCI procedure completion
Secondary outcomes (2)
PCI success
Successful PCI was defined as diameter stenosis of the target lesion ≤30%, no intraprocedure death, Q-wave or non-Q-wave myocardial infarction, or emergency coronary artery bypass grafting.
Measured: up to 7 days
Device success
Success of the device (successful balloon expansion) must meet the following conditions:
- Successfully complete the process of delivery, expansion, retraction and withdrawal;
- There was no balloon related vascular perforation, C-type or above dissection with limited blood flow, and TIMI grading was not lower than before balloon dilation.
Measured: through PCI procedure completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start8 Jun 2022
- Primary completion10 Apr 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- BrosMed Medical Co., Ltd
- Responsible party
- Principal investigator, Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Shao-Liang Chen, MD, PhD, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368129
- Sponsor's protocol ID
- NFH20220425
- Acronym
- POT-DES
- Status last verified
- Mar 2024
- First submitted
- 25 Apr 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After Drug-eluting Stent Implantation: a Prospective, Multicenter, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05368129
- Acronym / sponsor ID
- POT-DES / NFH20220425
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- BrosMed Medical Co., Ltd
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 10 May 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.
The objective of this randomized control trial is to gain clinical insight on the use of POT PTCA balloon dilatation catheter for the optimal dilation after drug-eluting stent implantation.
Detailed description
The current study is designed as a multicenter, randomized and prospective study aiming to compare the change in minimal stent area (MLA) of POT PTCA balloon dilatation catheter on patients with drug-eluting stent (DES) implantation. Based on the previous studies, the MLA in the proximal and distal 3mm segments was 7.38 mm^2 and 8.08 mm^2 before non-compliant balloon (NCB) dilation, respectively. After NCB dilation, that MSA in the proximal and distal 3mm segments was 7.53mm^2 and 9.55mm^2, respectively. As a result, a total of 48 patients with DES implantation are randomized at a ratio of 1:1 to either POT PTCA balloon dilatation catheter group (POT group) or Quantum Maverick balloon catheter group (NCB group) using a randomization schedule blocked by site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POT group | Experimental | Procedure: Balloon dilationA total of 24 patients are assigned to POT group after randomization schedule. |
| NCB group | Active comparator | Procedure: Balloon dilationA total of 24 patients are assigned to NCB group after randomization schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of informed consent prior to any study specific procedures;
- Men and women 18 years and older;
- Patients with asymptomatic myocardial ischemia, stable or unstable angina, or acute myocardial infarction with symptoms lasting more than 12 hours;
- The target lesions was de novo lesion;
- Reference vessel diameter of target lesion is between 2.25-4.0mm, and the lesion length is less than 15mm(visual inspection);
Key exclusion criteria (9 listed)
- Subjects had clinical symptoms and/or ECG changes consistent with ST-elevation myocardial infarction within 12 hours;
- Allergies to concomitant medications required by the balloon/stent system or protocol used in the study;
- Cannot tolerate dual antiplatelet therapy;
- Life expectancy is less than 6 months;
- Pregnant or lactating women;
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 |
|---|---|---|
| Balloon dilationBalloon dilation was performed after DES implantation. | Procedure or surgery | NCB group, POT group |
Primary outcome
Minimal stent area
Time frame: through PCI procedure completion
The change of minimum stent area measured by intravascular ultrasound.
2 secondary outcomes
PCI success
Time frame: up to 7 days
Device success
Time frame: through PCI procedure completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Shao-Liang Chen, MD, PhD study chair
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon dilation in people with Coronary Artery Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 21 Mar 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Minimal stent area (time frame: through PCI procedure completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2024.