Critical Lower Limb IschemiaINPACT-DEEPNCT00941733
Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia
A study testing IN.PACT Amphirion and Standard PTA in people with Critical Lower Limb Ischemia, run by Medtronic Endovascular at 13 sites in 6 countries.
Trial summary
This is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of the infrapopliteal vessels. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critical Lower Limb Ischemia
- What is being tested?
- IN.PACT Amphirion and Standard PTA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 13 sitesin 6 countries
- Study dates
- Sep 2009to 30 Nov 2017
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Inclusion Criteria
- Age ≥18 years and ≤85 years
- Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an Ethical Committee approved consent form
- Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation
- Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Category 4, 5 or 6
- Life expectancy >1 year in the Investigator's opinion
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- General Angiographic Inclusion Criteria
- Reference vessel(s) diameter between 2 and 4 mm
- Single or multiple lesions with ≥70% diameter stenosis (DS) of different lengths in one or more main afferent crural vessels including the tibioperoneal trunk
- At least one non occluded crural vessel with angiographically documented run-off to the foot either direct or through collaterals
- Angiographic Inclusion Criteria for Late Lumen Loss (LLL) assessment
- Angio-target lesion (TL) is one identifiable single solitary or series of multiple adjacent lesions with a diameter stenosis (DS) ≥70% and a cumulative length ≤100 mm that can be covered by a single IN.PACT Amphirion™ (10 mm balloon landing zone in both edges is mandatory)
- Angio-target lesion (TL) is the only lesion in that vessel (only one Angio-TL per patient is allowed)
Who cannot join
- General Exclusion Criteria
- Patient unwilling or unlikely to comply with Follow-Up schedule
- Planned major index limb amputation
- General Angiographic Exclusion Criteria
- Lesion and / or occlusions located or extending in the popliteal artery or below the ankle joint space
- Inflow lesion or occlusion in the ipsilateral Iliac, Superficial Femoral Artery (SFA), popliteal arteries with length ≥15 cm
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- Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral Iliac, Superficial Femoral Artery (SFA) and popliteal arteries left untreated
- Previously implanted stent in the target lesions(s)
- Aneurysm in the target vessel
- Acute thrombus in the target limb
- General Procedural Exclusion Criteria
- Failure to obtain a <30% residual stenosis in pre-existing, hemodynamically significant (≥50% diameter stenosis (DS) and <15 cm length) inflow lesions in the ipsilateral iliac, SFA and popliteal artery. No Drug Eluting Stents (DES) and / or Drug Eluting Balloon (DEB) allowed for the treatment of inflow lesions.
- Failure to cross the TL with a 0.014" guide wire
- Use of alternative therapy, e.g. atherectomy, cutting balloon, laser, radiation therapy, DES as part of the index procedure
- ANGIOGRAPHIC cohort General Exclusion Criteria:
- Glomerular Filtration Rate (GFR) <30 ml/min except for patients with renal end stage disease on chronic haemodialysis
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
Belgium4 sites
Imelda Hospital
Bonheiden
AZ Sint-Blasius
Dendermonde
ZOL St. Jan
Genk
Ghent University Hospital
Ghent
Germany4 sites
Herz-Zentrum Bad Krozingen
Bad Krozingen, 79189
Medical Care Center
Hamburg
University Hospital Heidelberg
Heidelberg
Park-Krankenhaus Leipzig
Leipzig, 04289
Switzerland2 sites
University of Bern
Bern, 3010
Luzerner Kantonsspital
Lucerne
About this study
Official title: Randomized Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA (Percutaneous Transluminal Angioplasty) for the Treatment of Below the Knee Critical Limb Ischemia
This is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of the infrapopliteal vessels. Patients will undergo a percutaneous transluminal endovascular procedure with either the IN.PACT Amphirion™ drug eluting balloon or with a standard (Percutaneous Transluminal Angioplasty) PTA balloon. Patients will be followed with pre-study, post-study, and follow-up evaluations.
- Conditions
- Critical Lower Limb Ischemia
- Being tested
- IN.PACT Amphirion, Standard PTA
- Keywords
- BTK, CLI, PTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN.PACT AmphirionDevice
Balloon Angioplasty
Standard PTADevice
Balloon Angioplasty
| Study group | Role | What they receive |
|---|---|---|
| Drug Eluting Balloon | Experimental | Intervention: IN.PACT Amphirion™ Receives: Device: IN.PACT Amphirion |
| Standard PTA | Active comparator | Intervention: Standard PTA Receives: Device: Standard PTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA)
The difference between minimum lumen diameter (MLD) immediately after Percutaneous Transluminal Angioplasty (PTA) and MLD at 12 months follow-up
Measured: 12 months or at Target Lesion Revascularization (TLR) time
Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients
Percentage of participants in the amputation free survival population with Clinically driven Target Lesion Revascularization (CD-TLR) at 12 months, CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s).
Measured: 12 months
Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR)
Percentage of participants experiencing all cause death, major amputation and clinically driven Target Lesion Revascularization (CD-TLR) at 6 months. CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s)
Measured: 6 months
Secondary outcomes (15)
Amputation Free Survival
Percentage of participants with a 1 year amputation free survival.
Measured: 12 months
Rate of Wound Healing
Percentage of participants with completed wound healing, wound healing as defined as core lab adjudication of > 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year.
Measured: 12 months
Amputation Free Survival and Wound Healing
Percentage of participants with a 1 year amputation free survival and wound healing. Wound healing is defined as core lab adjudication of > 50% area/volume reduction of baseline ulcer(s) in the treated leg at a specified time point.
Measured: 12 months
Amputation Free Survival and Resolved Critical Limb Ischemia (CLI)
Percentage of participants with an amputation free survival and resolved Critical Limb Ischemia (CLI) at 1 year.
Measured: 12 months
Death, Amputation and Clinically Driven Target Lesion Revascularization (TLR)
Percentage of participants that experienced death, amputation and clinically driven Target Lesion Revascularization (TLR) at 1 year.
Measured: 12 months
Primary Sustained Clinical Improvement
Percentage of participants that experienced primary sustained clinical improvement at 1 year, specified as an improvement shift in the Rutherford classification of one class in amputation free, clinically driven target lesion revascularization (TLR) free surviving subjects.
Measured: 12 months
Secondary Sustained Clinical Improvement
Percentage of participants that experienced a secondary sustained clinical improvement, specified as an improvement shift in the Rutherford classification of one class including the need for clinically driven TLR in amputation free surviving subjects at 1 year.
Measured: 12 months
Quality of Life Assessment by EQ5D
Quality of life assessment by EQ5D at 1 year compared to baseline. EQ-5D is a standardised measure of health status and economic appraisal. The EQ-5D-3L essentially consists of 2 parts:the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.
EQ-5D health states can be converted into a single summary index where 0.0='worst possible outcome' and 1.0='best possible outcome'.
Measured: 12 months
Walking Capacity Assessment
Walking Impairment assessment by WIQ at 1 year compared to baseline. The Walking Impairment Questionnaire (WIQ) is a questionnaire for evaluating walking impairment in patients with peripheral arterial disease (PAD). This can be used to identify patients with significant impairment and to monitor effectiveness of therapeutic interventions. The questionnaire was self-administered by the patients and contains three domains measuring three important factors of walking impairment in patients with intermittent claudication: (1) difficulty walking a distance during the past month, (2) difficulty walking at a certain speed during the past month, (3) symptoms associated with walking impairment. For each separate domain, a subscore was calculated. The total WIQ score was defined as the mean of the three subscores.
A WIQ score of 42.5 or less identified low performers; while a score of 75.5 or more identified high performers. The WIQ score range is 0 (minimum) - 100 (maximum).
Measured: 12 months
MAE (Major Adverse Events)
Percentage of participants with a MAE (Major Adverse Events) at 1 year. Major Adverse Events, defined as Death of any Cause, Major Amputation of target limb, Minor Amputation of target limb
Measured: 12 months
Device Success
Percentage of device success defined as exact deployment of the device according to the instructions for use as documented with suitable imaging modalities
Measured: Day 1
Technical Success
Percentage of technical success defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with less or equal to 50% residual diameter reduction of the treated lesion on completion angiography
Measured: Day 1
Procedural Success
Percentage of patients with a procedural success defined as combination of technical success, device success and absence of procedural complications
Measured: Day 1
Days of Hospitalization
Days of hospitalization at 1 year
Measured: 12 months
Improvement % Diameter Stenosis (%DS) of the Target Leasion (TL) Assessed by Quantitative Vascular Angiography (QVA)
Percentage of participants with an improvement in percent diameter stenosis (%DS) of the target leasion (TL) assessed by Quantitative Vascular Angiography (QVA)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2013
- Study completion30 Nov 2017
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Critical Lower Limb IschemiaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dierk Scheinert, MD, Principal investigator, Heart Center Leipzig - University HospitalThomas Zeller, MD, Principal investigator, University Heart Center Freiburg - Bad KrozingenIris Baumgartner, MD, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941733
- Sponsor's protocol ID
- P998
- Acronym
- INPACT-DEEP
- Status last verified
- Jan 2018
- First submitted
- 16 Jul 2009
- Last updated
- 28 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
PubMed 42573020Zeller T, Micari A, Scheinert D, Baumgartner I, Bosiers M, Vermassen FEG, Banyai M, Shishehbor MH, Wang H, Brodmann M; IN.PACT DEEP Trial Investigators. The IN.PACT DEEP Clinical Drug-Coated Balloon Trial: 5-Year Outcomes. JACC Cardiovasc Interv. 2020 Feb 24;13(4):431-443. doi: 10.1016/j.jcin.2019.10.059.
PubMed 32081236Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, Peeters P, Vermassen F, Landini M, Snead DB, Kent KC, Rocha-Singh KJ; IN.PACT DEEP Trial Investigators. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014 Oct 14;64(15):1568-76. doi: 10.1016/j.jacc.2014.06.1198.
PubMed 25301459Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, Peeters P, Vermassen F, Landini M; IN.PACT DEEP Trial Investigators. IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trial. Trials. 2014 Feb 19;15:63. doi: 10.1186/1745-6215-15-63.
PubMed 24552184
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA (Percutaneous Transluminal Angioplasty) for the Treatment of Below the Knee Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT00941733
- Acronym / sponsor ID
- INPACT-DEEP / P998
- Conditions
- Critical Lower Limb Ischemia
- Keywords
- BTK, CLI, PTA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 20 Jul 2009 (estimated)
- Results
- Posted 27 Oct 2014
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 prospective, multi-center, randomized (2:1) trial of symptomatic patients with critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of the infrapopliteal vessels. Patients will undergo a percutaneous transluminal endovascular procedure with either the IN.PACT Amphirion™ drug eluting balloon or with a standard (Percutaneous Transluminal Angioplasty) PTA balloon. Patients will be followed with pre-study, post-study, and follow-up evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Eluting Balloon | Experimental | Device: IN.PACT AmphirionIntervention: IN.PACT Amphirion™ |
| Standard PTA | Active comparator | Device: Standard PTAIntervention: Standard PTA |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- General Inclusion Criteria
- Age ≥18 years and ≤85 years
- Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an Ethical Committee approved consent form
- Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation
- Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Category 4, 5 or 6
Key exclusion criteria (16 listed)
- General Exclusion Criteria
- Patient unwilling or unlikely to comply with Follow-Up schedule
- Planned major index limb amputation
- General Angiographic Exclusion Criteria
- Lesion and / or occlusions located or extending in the popliteal artery or below the ankle joint space
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 |
|---|---|---|
| IN.PACT AmphirionBalloon Angioplasty | Device | Drug Eluting Balloon |
| Standard PTABalloon Angioplasty | Device | Standard PTA |
Primary outcome
Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA)
Time frame: 12 months or at Target Lesion Revascularization (TLR) time
The difference between minimum lumen diameter (MLD) immediately after Percutaneous Transluminal Angioplasty (PTA) and MLD at 12 months follow-up
Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients
Time frame: 12 months
Percentage of participants in the amputation free survival population with Clinically driven Target Lesion Revascularization (CD-TLR) at 12 months, CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s).
Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR)
Time frame: 6 months
Percentage of participants experiencing all cause death, major amputation and clinically driven Target Lesion Revascularization (CD-TLR) at 6 months. CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s)
15 secondary outcomes
Amputation Free Survival
Time frame: 12 months
Rate of Wound Healing
Time frame: 12 months
Amputation Free Survival and Wound Healing
Time frame: 12 months
Amputation Free Survival and Resolved Critical Limb Ischemia (CLI)
Time frame: 12 months
Death, Amputation and Clinically Driven Target Lesion Revascularization (TLR)
Time frame: 12 months
Primary Sustained Clinical Improvement
Time frame: 12 months
Secondary Sustained Clinical Improvement
Time frame: 12 months
Quality of Life Assessment by EQ5D
Time frame: 12 months
Walking Capacity Assessment
Time frame: 12 months
MAE (Major Adverse Events)
Time frame: 12 months
Device Success
Time frame: Day 1
Technical Success
Time frame: Day 1
Procedural Success
Time frame: Day 1
Days of Hospitalization
Time frame: 12 months
Improvement % Diameter Stenosis (%DS) of the Target Leasion (TL) Assessed by Quantitative Vascular Angiography (QVA)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42573020Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
- Derived from this study: PubMed 32081236Zeller T, Micari A, Scheinert D, Baumgartner I, Bosiers M, Vermassen FEG, Banyai M, Shishehbor MH, Wang H, Brodmann M; IN.PACT DEEP Trial Investigators. The IN.PACT DEEP Clinical Drug-Coated Balloon Trial: 5-Year Outcomes. JACC Cardiovasc Interv. 2020 Feb 24;13(4):431-443. doi: 10.1016/j.jcin.2019.10.059.
- Derived from this study: PubMed 25301459Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, Peeters P, Vermassen F, Landini M, Snead DB, Kent KC, Rocha-Singh KJ; IN.PACT DEEP Trial Investigators. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014 Oct 14;64(15):1568-76. doi: 10.1016/j.jacc.2014.06.1198.
- Derived from this study: PubMed 24552184Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, Peeters P, Vermassen F, Landini M; IN.PACT DEEP Trial Investigators. IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trial. Trials. 2014 Feb 19;15:63. doi: 10.1186/1745-6215-15-63.
- Zeller et al. Drug-Eluting Balloon Versus Standard Balloon Angioplasty for Infrapoplliteal Arterial Revascularization in CLI - 12-Month Results from the IN.PACT DEEP Randomized trial.Journal of the American College of Cardiology 2014; 64; 15Link provided by the sponsor.
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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.
Dierk Scheinert, MD principal investigator
Heart Center Leipzig - University Hospital
Thomas Zeller, MD principal investigator
University Heart Center Freiburg - Bad Krozingen
Iris Baumgartner, MD principal investigator
Insel Gruppe AG, University Hospital Bern
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IN.PACT Amphirion and Standard PTA in people with Critical Lower Limb Ischemia, run by Medtronic Endovascular at 13 sites in 6 countries.
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 13 inclusion and 16 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 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Belgium, Germany, Switzerland, Austria, Italy and 1 more country. 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 27 Oct 2014). 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?
Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA) (time frame: 12 months or at Target Lesion Revascularization (TLR) time). The study lists 3 primary outcomes in all. 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 NCT00941733, 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 28 Feb 2018.