StentsNCT03375411
First-in-Man Study: Safety and Efficacy of INC-1 Bare Metal Stent in the Novo Coronary Lesions.
A study testing Stent INC1 in people with Stents and Coronary Artery Disease, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
Trial summary
This is a First In Man study with the aim to know the safety and effectiveness of a novel bare metal stent (INC-1) in the treatment of de novo coronary lesions in patients with stable coronary angina and unique coronary lessions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stents, Coronary Artery Disease, Angioplasty
- What is being tested?
- Stent INC1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 30 Dec 2017to 25 Jan 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders.
- From 18 to 75 years
- Stable ischemic heart disease.
- Live less than 300 km from the Institution
- Single coronary artery disease with a single coronary lesion
- Stenosis of 50 to 90% of the lumen of the vessel to be treated.
- Lesions less than 20 mm long
- Reference lumen of the vessel to be treated greater than 2.5mm and less than 4.5mm
Who cannot join
- Left main disease.
- Lesions greater than 90% of the lumen.
- Non-dilatable lesion with conventional balloons.
- Contraindication for dual antiplatelet therapy.
- Creatinine clearance less than 45ml / min.
- Calcification from moderate to severe.
Show all 13Show fewer
- Multivessel coronary artery disease.
- Chronic total occlusion.
- Cardiogenic shock or hemodynamic instability.
- Left ventricular ejection fraction less than 30%.
- Valvular disease of moderate to severe.
- Coronary disease in bifurcation.
- Probable or definite presence of thrombus in the lesion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: INCSTENT First-in-Man Study: Safety and Efficacy of INC-1 Bare Metal Stent in the Novo Coronary Lesions.
This is a First In Man study with the aim to know the safety and effectiveness of a novel bare metal stent (INC-1) in the treatment of de novo coronary lesions in patients with stable coronary angina and unique coronary lessions.
Read the detailed description
The cost of performing a percutaneous coronary intervention is very variable since a large number of materials and human resources are considered, with the Stent cost being a fundamental factor; in developing countries, the cost this technology represents an important expense for the patient and the health system; which promotes the development of local technology to support the requirement of these devices.
Ischemic heart disease together with cerebral vascular events is the main cause of, adding 15 million deaths per year. Percutaneous revascularization is the gold standard choice in many of the variants of presentation of ischemic heart disease, the implantation of Stents is the most used method.
Nowadays more and more countries start their own research and development of novel devices in order to reduce cost.
Research question: Is the INC1 Bare Metal Stent safe and effective for the treatment of de novo coronary lesions in humans? Hypothesis: The INC1 Bare-metal Stent is safe and effective for the treatment of de novo coronary lesions in humans
The INC1 Bare metal Stent is a 70uCoCr
- Conditions
- Stents, Coronary Artery Disease, Angioplasty, Humans, Coronary Angiography, Angioplasty, Balloon, Coronary
- Being tested
- Stent INC1
- 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.
Stent INC1Device
Coronary intervention with conventional angioplasty technique but with a novel bare metal stent.
| Study group | Role | What they receive |
|---|---|---|
| INC1-Bare metal stent | Experimental | Percutaneous coronary implantation of the device (Stent INC-1) following the standard procedure of stent placement Receives: Device: Stent INC1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of late lumen loss [Safety and Tolerability])
The primary endpoint of the study is angiographic in-stent late lumen loss (LLL), defined as the difference between the post-procedural minimal lumen diameter (MLD) in the stented segment and the MLD in the same segment at follow-up measured by the angiography laboratory.
Measured: 9 months
Secondary outcomes (3)
Need of Revascularization
The Need of Revascularization of the treated vessel with a new angioplasty
Measured: 9 months
MACE
To evaluate the presence of major adverse cardiovascular events such (MACE) as cardiac death, myocardial infarction, new angina event or revascularization through surgery.
Measured: 9 months
Hyperplasia
To evaluate the degree of neointimal hyperplasia or at 9 months by intracoronary ultrasound.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start30 Dec 2017 (estimated)
- Primary completion15 Nov 2018 (estimated)
- Study completion25 Jan 2019 (estimated)
Why it stopped: CHANGE TO ANOTHER PLATFORM IN STUDY.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StentsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Collaborators
- GSE Biomedical, Medstent SA de CV.
- Responsible party
- Principal investigator, Gian Manuel Jiménez Rodríguez, Instituto Nacional de Cardiologia Ignacio Chavez
- Investigators
- Gian Manuel Jiménez Rodríguez, Principal investigator, Interventional Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375411
- Sponsor's protocol ID
- 17-1036
- Status last verified
- Oct 2022
- First submitted
- 30 Oct 2017
- Last updated
- 7 Oct 2022
- 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 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INCSTENT First-in-Man Study: Safety and Efficacy of INC-1 Bare Metal Stent in the Novo Coronary Lesions.
- ClinicalTrials.gov ID
- NCT03375411
- Acronym / sponsor ID
- 17-1036
- Conditions
- Stents, Coronary Artery Disease, Angioplasty, Humans, Coronary Angiography, Angioplasty, Balloon, Coronary
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: CHANGE TO ANOTHER PLATFORM IN STUDY.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Collaborators
- GSE Biomedical, Medstent SA de CV.
- Study start
- 30 Dec 2017 (estimated)
- Primary completion
- 15 Nov 2018 (estimated)
- Study completion
- 25 Jan 2019 (estimated)
- First posted
- 18 Dec 2017 (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 is a First In Man study with the aim to know the safety and effectiveness of a novel bare metal stent (INC-1) in the treatment of de novo coronary lesions in patients with stable coronary angina and unique coronary lessions.
Detailed description
The cost of performing a percutaneous coronary intervention is very variable since a large number of materials and human resources are considered, with the Stent cost being a fundamental factor; in developing countries, the cost this technology represents an important expense for the patient and the health system; which promotes the development of local technology to support the requirement of these devices.
Ischemic heart disease together with cerebral vascular events is the main cause of, adding 15 million deaths per year. Percutaneous revascularization is the gold standard choice in many of the variants of presentation of ischemic heart disease, the implantation of Stents is the most used method.
Nowadays more and more countries start their own research and development of novel devices in order to reduce cost.
Research question: Is the INC1 Bare Metal Stent safe and effective for the treatment of de novo coronary lesions in humans? Hypothesis: The INC1 Bare-metal Stent is safe and effective for the treatment of de novo coronary lesions in humans
The INC1 Bare metal Stent is a 70uCoCr
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INC1-Bare metal stent | Experimental | Device: Stent INC1Percutaneous coronary implantation of the device (Stent INC-1) following the standard procedure of stent placement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Both genders.
- From 18 to 75 years
- Stable ischemic heart disease.
- Live less than 300 km from the Institution
- Single coronary artery disease with a single coronary lesion
Key exclusion criteria (13 listed)
- Left main disease.
- Lesions greater than 90% of the lumen.
- Non-dilatable lesion with conventional balloons.
- Contraindication for dual antiplatelet therapy.
- Creatinine clearance less than 45ml / min.
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 |
|---|---|---|
| Stent INC1Coronary intervention with conventional angioplasty technique but with a novel bare metal stent. | Device | INC1-Bare metal stent |
Primary outcome
Incidence of late lumen loss [Safety and Tolerability])
Time frame: 9 months
The primary endpoint of the study is angiographic in-stent late lumen loss (LLL), defined as the difference between the post-procedural minimal lumen diameter (MLD) in the stented segment and the MLD in the same segment at follow-up measured by the angiography laboratory.
3 secondary outcomes
Need of Revascularization
Time frame: 9 months
MACE
Time frame: 9 months
Hyperplasia
Time frame: 9 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- 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.
Gian Manuel Jiménez Rodríguez principal investigator
Interventional Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent INC1 in people with Stents and Coronary Artery Disease, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
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 13 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: withdrawn, as of the sponsor's last update on 7 Oct 2022. 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 Mexico. 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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of late lumen loss [Safety and Tolerability]) (time frame: 9 months). 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 7 Oct 2022.