Coronary Artery DiseaseROTA-CUTNCT04865588
Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions
A study testing rotational atherectomy, cutting balloon and plain old balloon in people with Coronary Artery Disease and Atherosclerosis, run by Samin Sharma, M.D., F.A.C.C., M.S.C.A.I. at 2 sites in United States.
Trial summary
Rotational atherectomy is an established tool to treat blocked arteries in the heart, in which the blockage is due to significant amounts of calcified material. In rotational atherectomy, a rotating instrument is used to break up the calcification before a stent is placed and helps restore blood flow to the heart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis
- What is being tested?
- rotational atherectomy, cutting balloon and plain old balloon
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 May 2022to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults Patients ≥18 years of age
- Patients undergoing percutaneous coronary intervention with planned rotational atherectomy and planned drug-eluting stent implantation of a lesion with target vessel reference diameter ≥2.5 mm and ≤ 4.0mm, lesion length ≥ 5 mm and moderate to severe calcification by angiography
- Patients eligible for percutaneous coronary intervention
Who cannot join
- Patients in cardiogenic shock
- Planned surgery (cardiac and non-cardiac) within 6 months after the index procedure unless the dual-antiplatelet therapy can be maintained throughout the perisurgical period
- Patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction
- Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, < 2 years postmenopausal, or does not consistently use effective methods of contraception
- Patient has any other serious medical illness (e.g., cancer, end-stage congestive heart failure) that may reduce life expectancy to less than 12 months
- Currently participating in another investigational drug or device study
Show all 15Show fewer
- Patients referred to coronary artery bypass grafting after heart team discussion
- Angiographic Specific Exclusion Criteria:
- Lesion(s) with angulation > 45 degrees by visual estimate
- Lesion(s) stenosis through which a guidewire will not pass.
- Last remaining vessel with compromised (<30%) left ventricular function
- Saphenous vein grafts
- Angiographic evidence of thrombus
- Angiographic evidence of significant dissection at the treatment site
- Lesion(s) with previously placed stent within 10 mm (visual estimate)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Saint Francis Hospital and Heart Center
Roslyn, New York, 11576
About this study
Rotational atherectomy is an established tool to treat blocked arteries in the heart, in which the blockage is due to significant amounts of calcified material. In rotational atherectomy, a rotating instrument is used to break up the calcification before a stent is placed and helps restore blood flow to the heart. However, severely calcified regions are difficult to treat and even after treatment arteries can re-clog and major cardiac events occur. This study will test if rotational atherectomy with the addition of a cutting balloon - a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs - will result in increased blood vessel lumen, more optimal stent expansion and decreased cardiac problems compared to current standard treatment.
Read the detailed description
This is a prospective, pilot study randomizing patients with stable Coronary Artery Disease undergoing Percutaneous Coronary Intervention for a de novo calcified lesion with drug eluting stent implantation to angioplasty with rotational atherectomy followed by cutting balloon (ROTA + CBA) or rotational atherectomy followed by plain old balloon (ROTA + POBA) in a 1:1 ratio.
The clinical investigation will be conducted at 2 centers in the US. Up to 48 randomized subjects per site will be enrolled in this study. Subjects participating in this clinical investigation will be followed for 9 months. The expected duration of enrollment is approximately 6 months. The total duration of the clinical investigation is expected to be approximately 2 years.
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Being tested
- rotational atherectomy, cutting balloon, plain old balloon
- Keywords
- calcified plaque, angioplasty, cutting balloon
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rotational atherectomyProcedure or surgery
angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification
cutting balloonDevice
a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs
plain old balloonDevice
current standard treatment of stent placement
| Study group | Role | What they receive |
|---|---|---|
| rotational atherectomy + cutting balloon | Active comparator | angioplasty with rotational atherectomy followed by cutting balloon Receives: Procedure: rotational atherectomy; Device: cutting balloon |
| rotational atherectomy + plain old balloon | Active comparator | angioplasty with rotational atherectomy followed by plain old balloon Receives: Procedure: rotational atherectomy; Device: plain old balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum Stent Area After Percutaneous Coronary Intervention
Post-procedure minimum stent area after percutaneous coronary intervention assessed by intravascular ultrasound (IVUS)
Measured: Post-procedure, Day 0
Secondary outcomes (30)
In-segment Minimum Lumen Area After Stent Implantation and Post Dilatation
In-segment Minimum lumen area after stent implantation and post dilatation assessed by intravascular ultrasound
Measured: Post-procedure, Day 0
Minimum Percent Stent Expansion After Percutaneous Coronary Intervention
Minimum percent stent expansion after Percutaneous Coronary Intervention assessed by intravascular ultrasound
Measured: Post-procedure, Day 0
Mean Percent Stent Expansion After Percutaneous Coronary Intervention
Mean percent stent expansion after percutaneous coronary intervention assessed by intravascular ultrasound
Measured: Post-procedure, Day 0
Number of Participants With Dissection After Percutaneous Coronary Intervention
Number of Participants with Dissection after Percutaneous Coronary Intervention assessed by intravascular ultrasound.
Measured: Post-procedure, Day 0
Number of Participants With Stent Malapposition After Percutaneous Coronary Intervention
Number of Participants with Stent malapposition after Percutaneous Coronary Intervention assessed by intravascular ultrasound. Malapposition is indicated by blood visible behind stent struts. Stents may be completely or only partially malapposed depending on how much of the stent is in contact with the lumen wall.
Measured: Post-Procedure, Day 0
Number of Participants With Dissection After Rotational Atherectomy and Cutting Balloon Angioplasty /Non-compliant Balloon Angioplasty (CBA/NCBA)
Number of Participants with Dissection after Rotational atherectomy and cutting balloon angioplasty /non-compliant balloon angioplasty (CBA/NCBA) assessed by intravascular ultrasound. A dissection or tear in the vessel wall
Measured: Post-CBA/NCBA before stent, Day 0
Number of Participants With a Calcium Fracture After Rotational Atherectomy and Cutting/Plain Old Balloon
Number of Participants with a Calcium fracture after Rotational atherectomy and Cutting/Plain old balloon assessed by intravascular ultrasound. A fracture within the calcified area.
Measured: Post-Procedure, Day 0
Acute Lumen Gain In-segment After Stent Implantation Assessed by Angiography
Defined as the minimal luminal diameter in stent after stent implantation minus the minimal luminal diameter at baseline (prior to percutaneous coronary intervention and/or prior to stent placement).
Measured: Post-procedure, Day 0
Acute Lumen Gain In-stent After Stent Implantation Assessed by Angiography
Defined as the minimal luminal diameter in segment after stent implantation minus the minimal luminal diameter at baseline (prior to percutaneous coronary intervention and/or prior to stent placement).
Measured: Post-procedure, Day 0
Percent Residual Diameter Stenosis In-segment After Stent Implantation
Percent Residual diameter stenosis in-segment after stent implantation assessed by Angiography
Measured: Post-procedure, Day 0
Percent Residual Diameter Stenosis In-stent After Stent Implantation
Percent Residual diameter stenosis in-stent after stent implantation assessed by Angiography
Measured: Post-procedure, Day 0
Minimum Lumen Diameter In-segment After Stent Implantation
Minimum lumen diameter in-segment after stent implantation assessed by Angiography
Measured: Post-procedure, Day 0
Minimum Lumen Diameter In-stent After Stent Implantation
Minimum lumen diameter in-stent after stent implantation assessed by Angiography
Measured: Post-procedure, Day 0
Number of Participants With Dissection Type B or Greater
Number of Participants with Dissection Type B or greater before and after stent implantation assessed by Angiography.
Measured: Post-CBA/NCBA before stent and after stent, Day 0
Number of Participants With Perforation (Ellis Type ≥2) After Stent Implantation
Number of Participants with perforation (Ellis type ≥2) after stent implantation assessed by Angiography. Perforation of a vessel
Measured: Post-procedure, Day 0
Number of Participants With Side Branch Closure After Stent Implantation
Number of Participants with side branch closure after stent implantation assessed by Angiography. Occlusion of a side branch
Measured: Post-procedure, Day 0
Number of Participants With a Balloon Rupture
Device problem; Rupture of the cutting balloon or plain old balloon
Measured: Post-Procedure, Day 0
Number of Participants With Blade Detachment
Device problem; detachment of a blade from the cutting balloon
Measured: Post-Procedure, Day 0
Number of Participants With Difficulty in Withdrawing/Advancing the Device
Device problem; difficulty in moving the balloon within the vessel during the procedure
Measured: Post-Procedure, Day 0
Number of Participants Who Died of All-causes (Cardiac and Non-cardiac) After Percutaneous Coronary Intervention
Measured: 30 days
Number of Participants Who Died of Cardiac Death After Percutaneous Coronary Intervention
Cardiac Death
Measured: 30 days
Number of Participants Who Died of Non-Cardiac Death After Percutaneous Coronary Intervention
Non-Cardiac Death
Measured: 30 days
Number of Participants With Myocardial Infarction, as Defined by the Society for Cardiovascular Angiography and Intervention (SCAI), After Percutaneous Coronary Intervention
The Society for Cardiovascular Angiography and Intervention (SCAI) defines clinically relevant MI after PCI as an elevation of cardiac biomarkers (CK-MB or troponin) above specified thresholds within 48 hours of the procedure, with or without new Q waves or LBBB on ECG. This definition aims to identify meaningful ischemic injury to the myocardium that is associated with adverse clinical outcomes.
Measured: 30 days
Percent of Participants With Myocardial Infarction, as Defined by 4th Universal Definition, After Percutaneous Coronary Intervention
Myocardial infarction is defined as heart muscle damage due to lack of blood flow, based on characteristic symptoms, ECG changes, and cardiac biomarker elevation, especially troponin. Elevated levels of cardiac biomarkers, especially troponin, along with ECG changes and cardiac symptoms, indicate myocardial infarction according to the universal definition.
Measured: 30 days
Number of Participants With Target Lesion Revascularization After Percutaneous Coronary Intervention
Revascularization
Measured: 30 days
Number of Participants With Target Vessel Revascularization After Percutaneous Coronary Intervention
Revascularization
Measured: 30 days
Number of Participants With Stent Thrombosis (Definite/Probable) After Percutaneous Coronary Intervention
Stent Thrombosis
Measured: 30 days
Number of Participants With Major Bleeding (BARC 3 or 5) After Percutaneous Coronary Intervention
Bleeding Academic Research Consortium (BARC) Type 3
- Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding
- Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents
- Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision
Type 5
- Probable fatal bleeding
- Definite fatal bleeding (overt or autopsy or imaging confirmation)
Measured: 30 days
Number of Participants With Vascular Complications After Percutaneous Coronary Intervention
Vascular complication
Measured: 30 days
Angina Status According to Canadian Cardiovascular Society (CSS) Classification
The Canadian Cardiovascular Society (CCS) grading scale is a classification system used to grade the severity of angina pectoris based on symptoms and their relationship to physical activity.
Grade I: Ordinary physical activity like walking does not cause angina. Angina only occurs with strenuous, rapid, prolonged exertion during recreation or work.
Grade II: Slight limitation of ordinary activity. Angina occurs when walking/climbing stairs rapidly, walking uphill, after meals, in cold/wind, under stress, or early morning. Angina occurs when walking more than 2 blocks or climbing more than 1 flight of stairs at a normal pace.
Grade III: Marked limitation of ordinary activity. Angina occurs when walking 1-2 blocks or climbing 1 flight of stairs at a normal pace.
Grade IV: Inability to carry out any physical activity without angina. Anginal symptoms may be present at rest.
Higher grades indicate more limitations to activity due to angina.
Measured: 270 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start13 May 2022
- Primary completion4 Apr 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samin Sharma, M.D., F.A.C.C., M.S.C.A.I., Icahn School of Medicine at Mount Sinai
- Investigators
- Samin K Sharma, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865588
- Sponsor's protocol ID
- GCO 21-0532
- Acronym
- ROTA-CUT
- Status last verified
- Apr 2024
- First submitted
- 14 Apr 2021
- Last updated
- 22 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions
- ClinicalTrials.gov ID
- NCT04865588
- Acronym / sponsor ID
- ROTA-CUT / GCO 21-0532
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Keywords
- calcified plaque, angioplasty, cutting balloon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.University, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Posted 22 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rotational atherectomy is an established tool to treat blocked arteries in the heart, in which the blockage is due to significant amounts of calcified material. In rotational atherectomy, a rotating instrument is used to break up the calcification before a stent is placed and helps restore blood flow to the heart. However, severely calcified regions are difficult to treat and even after treatment arteries can re-clog and major cardiac events occur. This study will test if rotational atherectomy with the addition of a cutting balloon - a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs - will result in increased blood vessel lumen, more optimal stent expansion and decreased cardiac problems compared to current standard treatment.
Detailed description
This is a prospective, pilot study randomizing patients with stable Coronary Artery Disease undergoing Percutaneous Coronary Intervention for a de novo calcified lesion with drug eluting stent implantation to angioplasty with rotational atherectomy followed by cutting balloon (ROTA + CBA) or rotational atherectomy followed by plain old balloon (ROTA + POBA) in a 1:1 ratio.
The clinical investigation will be conducted at 2 centers in the US. Up to 48 randomized subjects per site will be enrolled in this study. Subjects participating in this clinical investigation will be followed for 9 months. The expected duration of enrollment is approximately 6 months. The total duration of the clinical investigation is expected to be approximately 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| rotational atherectomy + cutting balloon | Active comparator | Procedure: rotational atherectomy, Device: cutting balloonangioplasty with rotational atherectomy followed by cutting balloon |
| rotational atherectomy + plain old balloon | Active comparator | Procedure: rotational atherectomy, Device: plain old balloonangioplasty with rotational atherectomy followed by plain old balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults Patients ≥18 years of age
- Patients undergoing percutaneous coronary intervention with planned rotational atherectomy and planned drug-eluting stent implantation of a lesion with target vessel reference diameter ≥2.5 mm and ≤ 4.0mm, lesion length ≥ 5 mm and moderate to severe calcification by angiography
- Patients eligible for percutaneous coronary intervention
Key exclusion criteria (15 listed)
- Patients in cardiogenic shock
- Planned surgery (cardiac and non-cardiac) within 6 months after the index procedure unless the dual-antiplatelet therapy can be maintained throughout the perisurgical period
- Patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction
- Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, < 2 years postmenopausal, or does not consistently use effective methods of contraception
- Patient has any other serious medical illness (e.g., cancer, end-stage congestive heart failure) that may reduce life expectancy to less than 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 |
|---|---|---|
| rotational atherectomyangioplasty with rotational atherectomy - a rotating instrument used to break up the calcification | Procedure or surgery | rotational atherectomy + cutting balloon, rotational atherectomy + plain old balloon |
| cutting balloona balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | Device | rotational atherectomy + cutting balloon |
| plain old ballooncurrent standard treatment of stent placement | Device | rotational atherectomy + plain old balloon |
Primary outcome
Minimum Stent Area After Percutaneous Coronary Intervention
Time frame: Post-procedure, Day 0
Post-procedure minimum stent area after percutaneous coronary intervention assessed by intravascular ultrasound (IVUS)
30 secondary outcomes
In-segment Minimum Lumen Area After Stent Implantation and Post Dilatation
Time frame: Post-procedure, Day 0
Minimum Percent Stent Expansion After Percutaneous Coronary Intervention
Time frame: Post-procedure, Day 0
Mean Percent Stent Expansion After Percutaneous Coronary Intervention
Time frame: Post-procedure, Day 0
Number of Participants With Dissection After Percutaneous Coronary Intervention
Time frame: Post-procedure, Day 0
Number of Participants With Stent Malapposition After Percutaneous Coronary Intervention
Time frame: Post-Procedure, Day 0
Number of Participants With Dissection After Rotational Atherectomy and Cutting Balloon Angioplasty /Non-compliant Balloon Angioplasty (CBA/NCBA)
Time frame: Post-CBA/NCBA before stent, Day 0
Number of Participants With a Calcium Fracture After Rotational Atherectomy and Cutting/Plain Old Balloon
Time frame: Post-Procedure, Day 0
Acute Lumen Gain In-segment After Stent Implantation Assessed by Angiography
Time frame: Post-procedure, Day 0
Acute Lumen Gain In-stent After Stent Implantation Assessed by Angiography
Time frame: Post-procedure, Day 0
Percent Residual Diameter Stenosis In-segment After Stent Implantation
Time frame: Post-procedure, Day 0
Percent Residual Diameter Stenosis In-stent After Stent Implantation
Time frame: Post-procedure, Day 0
Minimum Lumen Diameter In-segment After Stent Implantation
Time frame: Post-procedure, Day 0
Minimum Lumen Diameter In-stent After Stent Implantation
Time frame: Post-procedure, Day 0
Number of Participants With Dissection Type B or Greater
Time frame: Post-CBA/NCBA before stent and after stent, Day 0
Number of Participants With Perforation (Ellis Type ≥2) After Stent Implantation
Time frame: Post-procedure, Day 0
Number of Participants With Side Branch Closure After Stent Implantation
Time frame: Post-procedure, Day 0
Number of Participants With a Balloon Rupture
Time frame: Post-Procedure, Day 0
Number of Participants With Blade Detachment
Time frame: Post-Procedure, Day 0
Number of Participants With Difficulty in Withdrawing/Advancing the Device
Time frame: Post-Procedure, Day 0
Number of Participants Who Died of All-causes (Cardiac and Non-cardiac) After Percutaneous Coronary Intervention
Time frame: 30 days
Number of Participants Who Died of Cardiac Death After Percutaneous Coronary Intervention
Time frame: 30 days
Number of Participants Who Died of Non-Cardiac Death After Percutaneous Coronary Intervention
Time frame: 30 days
Number of Participants With Myocardial Infarction, as Defined by the Society for Cardiovascular Angiography and Intervention (SCAI), After Percutaneous Coronary Intervention
Time frame: 30 days
Percent of Participants With Myocardial Infarction, as Defined by 4th Universal Definition, After Percutaneous Coronary Intervention
Time frame: 30 days
Number of Participants With Target Lesion Revascularization After Percutaneous Coronary Intervention
Time frame: 30 days
Number of Participants With Target Vessel Revascularization After Percutaneous Coronary Intervention
Time frame: 30 days
Number of Participants With Stent Thrombosis (Definite/Probable) After Percutaneous Coronary Intervention
Time frame: 30 days
Number of Participants With Major Bleeding (BARC 3 or 5) After Percutaneous Coronary Intervention
Time frame: 30 days
Number of Participants With Vascular Complications After Percutaneous Coronary Intervention
Time frame: 30 days
Angina Status According to Canadian Cardiovascular Society (CSS) Classification
Time frame: 270 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Samin K Sharma, MD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rotational atherectomy, cutting balloon and plain old balloon in people with Coronary Artery Disease and Atherosclerosis, run by Samin Sharma, M.D., F.A.C.C., M.S.C.A.I. at 2 sites in United States.
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 3 inclusion and 15 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 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 22 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Minimum Stent Area After Percutaneous Coronary Intervention (time frame: Post-procedure, Day 0). 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 22 May 2024.