RestenosisPHOTOPACNCT01298947
Photoablative Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis in Instent Femoro-popliteal Obstructions
A study testing Laser Atherectomy (Spectranetics CE marked peripheral laser atherectomy catheters (including Turbo Elite®), Turbo-Booster® and Turbo Tandem™ Systems in people with Restenosis, run by Herz-Zentrums Bad Krozingen.
Trial summary
The objective of this study is to evaluate the safety and efficacy of preparing a vessel with photoablation with Spectranetics CVX-300® Excimer laser and laser catheters prior to local Paclitaxel delivery compared to local Paclitaxel delivery without initial photoablation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restenosis
- What is being tested?
- Laser Atherectomy (Spectranetics CE marked peripheral laser atherectomy catheters (including Turbo Elite®), Turbo-Booster® and Turbo Tandem™ Systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Apr 2013
- 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
- Subject must meet all of the following general inclusion criteria.
- Has a Rutherford Clinical Category Score of 1 - 5.
- Is willing and capable of complying with all follow-up evaluations at the specified times.
- Is ≥ 18 years old.
- Provides written informed consent prior to study specific procedures.
Who cannot join
- The subject must not meet any of the following general exclusion criteria.
- Has contraindications listed in any study device IFUs.
- Has a contraindication or known untreated allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug anticipated to be used.
- Has a hypersensitivity to contrast material that cannot be adequately pretreated.
- Has known hypersensitivity to treatment device materials including Paclitaxel. Has known uncontrollable hypercoagulable condition, or refuses blood transfusion.
- 6. Has life expectancy of less than 12 months. 7. Is pregnant, of childbearing potential not taking adequate contraceptives, or nursing.
Show all 12Show fewer
- 8. Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure.
- 9. Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure.
- 10. Is currently participating in an investigational drug or another device study that may clinically interfere with the study outcomes.
- 11. Any co-morbid condition that in the judgment of the physician precludes safe percutaneous intervention.
- 12. Has had a previous peripheral bypass affecting the target vessel. 13. Has chronic renal insufficiency with creatinine > 2.5 mg/L (except patients under chronic renal replacement therapy).
- 14. Is unable or unwilling to receive dual anti-platelet therapy. 15. Equipment is unavailable to fulfill study treatments.
About this study
The objective of this study is to evaluate the safety and efficacy of preparing a vessel with photoablation with Spectranetics CVX-300® Excimer laser and laser catheters prior to local Paclitaxel delivery compared to local Paclitaxel delivery without initial photoablation
Read the detailed description
This is a prospective, two-arm randomized study. The control cohort (PTX PTA group, Admiral Inpact or Pacific Inpact, Medtronic-Invatec) will be treated with a PTX-coated PTA balloon. The experimental cohort (Laser+PTX PTA group) will be treated with photoablative atherectomy followed by a PTX-coated PTA balloon. Subjects meeting the definitions of Rutherford Clinical Categories 1 to 5 with instent lesions located in superficial femoral artery and the popliteal artery above the knee joint are eligible for enrollment.
The purpose of this feasibility study is to evaluate the safety and effectiveness of preparing an instent lesion with photoablative atherectomy prior to local Paclitaxel delivery compared to local Paclitaxel delivery without initial photoablative atherectomy.
Primary Outcome:
Target Lesion Percent Diameter Stenosis (%DS) at 1 Year defined as the narrowest point of the target lesion divided by the estimated native vessel diameter at that location as determined by the ACL.
Secondary Outcomes:
The following secondary outcomes will be summarized in this study.
- Procedural Success: Defined as ≤ 30% residual stenosis following the procedure at the target lesion, without periprocedural complications, as determined by the ACL.
- Major Adverse Event Rate at 30 Days and 1 Year: Defined as major unplanned amputation of the treated limb, all-cause mortality within 1 year of the index procedure or clinically-driven target vessel revascularization within 30 days of the index procedure.
- Improvement in WIQ Score at 6 Months and 1 Year: Defined as an increase in Walking Impairment Questionnaire (WIQ) score at 6 months and 1 year compared to baseline.
- Improvement in EQ-5D Score at 6 Months and 1 Year: Defined as an increase in the EQ-5D questionnaire score at 6 months and 1 year compared to baseline.
- Improvement in Rutherford Clinical Category at 6 Months and 1 Year: Defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category at 6 months and 1 year compared to baseline, that is attributable to the target limb (in cases of bilateral disease).
- Improvement in Ankle-Brachial Index at 6 Months and 1 Year: Defined as an increase in the ankle-brachial index (ABI) at 6 months and 1 year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9.
- Clinically-Driven Target Lesion Revascularization (TLR) at 6 Months and 1 Year. Defined as any reintervention or artery bypass graft surgery involving the target lesion in which the subject has ≥ 50% diameter stenosis in the presence of recurrent symptoms (i.e. claudication) or ≥ 70% stenosis without any symptoms (i.e. decreased ABI).
- Patency Rate (Peak Systolic Velocity ≤ 3.5) at 6 \& 12 Months: Defined by duplex ultrasound core lab measurement of peak systolic velocity (PSV) ratio ≤ 3.5 at the target lesion with no clinically-driven reintervention within the target lesion.
- Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) at 6 \& 12 Months: Defined by duplex ultrasound core lab measurement of peak systolic velocity (PSV) ratio ≤ 2.4 at the target lesion with no clinically-driven reintervention within the target lesion.
- Minimum Lumen Diameter at 1 Year: Determined by angiographic assessment of the target lesion at 1 year by the ACL.
- Net Lumen Gain at 1 Year: Defined as the difference between the target lesion MLD at baseline and 1 year following the index procedure per angiographic assessment determined by the ACL.
- Patency Rate at 1 Year: Defined as ≤ 70% stenosis per angiography as determined by the ACL.
- Secondary Patency Rate at 1 Year: Defined as ≤ 70% stenosis per angiography as determined by the ACL, maintained by repeat percutaneous intervention.
- Conditions
- Restenosis
- Being tested
- Laser Atherectomy (Spectranetics CE marked peripheral laser atherectomy catheters (including Turbo Elite®), Turbo-Booster® and Turbo Tandem™ Systems
- Keywords
- Photoablative Atherectomy, Paclitaxel-Coated Balloon, Instent Femoro-popliteal Obstructions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Atherectomy (Spectranetics CE marked peripheral laser atherectomy catheters (including Turbo Elite®), Turbo-Booster® and Turbo Tandem™ SystemsDevice
comparing the use of a Paclitaxel-eluting angioplasty balloon (PTX PTA) with initial photoablation to the use of PTX PTA alone in the treatment of instent lesions in femoropopliteal arteries
| Study group | Role | What they receive |
|---|---|---|
| Laser atherectomy and drug-coated balloon | Active comparator | Laser atherectomy and Paclitaxel-coated balloon angioplasty in treatment of instent lesions of femoropopliteal arteries Receives: Device: Laser Atherectomy (Spectranetics CE marked peripheral laser atherectomy catheters (including Turbo Elite®), Turbo-Booster® and Turbo Tandem™ Systems |
| Drug eluting Ballon PTA | Active comparator | Paclitaxel-coated balloon angioplasty Receives: Device: Laser Atherectomy (Spectranetics CE marked peripheral laser atherectomy catheters (including Turbo Elite®), Turbo-Booster® and Turbo Tandem™ Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Percent Stenosis
Target Lesion Percent Stenosis at 1 Year: Defined as the narrowest point of the target lesion divided by the estimated native vessel diameter at that location as determined by the angiographic core lab.
Measured: at 1 Year
Secondary outcomes (1)
Procedural Success
Defined as ≤ 30% residual stenosis following the procedure at the target lesion, without periprocedural complications, as determined by the angiographic core lab.
Major Adverse Event Rate at 30 Days and 1 Year: Defined as, major unplanned amputation of the treated limb, all-cause mortality within 1 year of the index procedure or clinically-driven target vessel revascularization within 30 days and 1 year of the index procedure.
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RestenosisStudies 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herz-Zentrums Bad Krozingen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298947
- Sponsor's protocol ID
- PHOTOPAC
- Acronym
- PHOTOPAC
- Status last verified
- Feb 2011
- First submitted
- 17 Feb 2011
- Last updated
- 21 Feb 2011
- Results posted
- No
- 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 42573020
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photoablative Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis in Instent Femoro-popliteal Obstructions
- ClinicalTrials.gov ID
- NCT01298947
- Acronym / sponsor ID
- PHOTOPAC / PHOTOPAC
- Conditions
- Restenosis
- Keywords
- Photoablative Atherectomy, Paclitaxel-Coated Balloon, Instent Femoro-popliteal Obstructions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Herz-Zentrums Bad KrozingenUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 18 Feb 2011 (estimated)
- 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 study is to evaluate the safety and efficacy of preparing a vessel with photoablation with Spectranetics CVX-300® Excimer laser and laser catheters prior to local Paclitaxel delivery compared to local Paclitaxel delivery without initial photoablation
Detailed description
This is a prospective, two-arm randomized study. The control cohort (PTX PTA group, Admiral Inpact or Pacific Inpact, Medtronic-Invatec) will be treated with a PTX-coated PTA balloon. The experimental cohort (Laser+PTX PTA group) will be treated with photoablative atherectomy followed by a PTX-coated PTA balloon. Subjects meeting the definitions of Rutherford Clinical Categories 1 to 5 with instent lesions located in superficial femoral artery and the popliteal artery above the knee joint are eligible for enrollment.
The purpose of this feasibility study is to evaluate the safety and effectiveness of preparing an instent lesion with photoablative atherectomy prior to local Paclitaxel delivery compared to local Paclitaxel delivery without initial photoablative atherectomy.
Primary Outcome:
Target Lesion Percent Diameter Stenosis (%DS) at 1 Year defined as the narrowest point of the target lesion divided by the estimated native vessel diameter at that location as determined by the ACL.
Secondary Outcomes:
The following secondary outcomes will be summarized in this study.
- Procedural Success: Defined as ≤ 30% residual stenosis following the procedure at the target lesion, without periprocedural complications, as determined by the ACL.
- Major Adverse Event Rate at 30 Days and 1 Year: Defined as major unplanned amputation of the treated limb, all-cause mortality within 1 year of the index procedure or clinically-driven target vessel revascularization within 30 days of the index procedure.
- Improvement in WIQ Score at 6 Months and 1 Year: Defined as an increase in Walking Impairment Questionnaire (WIQ) score at 6 months and 1 year compared to baseline.
- Improvement in EQ-5D Score at 6 Months and 1 Year: Defined as an increase in the EQ-5D questionnaire score at 6 months and 1 year compared to baseline.
- Improvement in Rutherford Clinical Category at 6 Months and 1 Year: Defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category at 6 months and 1 year compared to baseline, that is attributable to the target limb (in cases of bilateral disease).
- Improvement in Ankle-Brachial Index at 6 Months and 1 Year: Defined as an increase in the ankle-brachial index (ABI) at 6 months and 1 year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9.
- Clinically-Driven Target Lesion Revascularization (TLR) at 6 Months and 1 Year. Defined as any reintervention or artery bypass graft surgery involving the target lesion in which the subject has ≥ 50% diameter stenosis in the presence of recurrent symptoms (i.e. claudication) or ≥ 70% stenosis without any symptoms (i.e. decreased ABI).
- Patency Rate (Peak Systolic Velocity ≤ 3.5) at 6 \& 12 Months: Defined by duplex ultrasound core lab measurement of peak systolic velocity (PSV) ratio ≤ 3.5 at the target lesion with no clinically-driven reintervention within the target lesion.
- Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) at 6 \& 12 Months: Defined by duplex ultrasound core lab measurement of peak systolic velocity (PSV) ratio ≤ 2.4 at the target lesion with no clinically-driven reintervention within the target lesion.
- Minimum Lumen Diameter at 1 Year: Determined by angiographic assessment of the target lesion at 1 year by the ACL.
- Net Lumen Gain at 1 Year: Defined as the difference between the target lesion MLD at baseline and 1 year following the index procedure per angiographic assessment determined by the ACL.
- Patency Rate at 1 Year: Defined as ≤ 70% stenosis per angiography as determined by the ACL.
- Secondary Patency Rate at 1 Year: Defined as ≤ 70% stenosis per angiography as determined by the ACL, maintained by repeat percutaneous intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser atherectomy and drug-coated balloon | Active comparator | Device: Laser Atherectomy (Spectranetics CE marked peripheral laser atherectomy catheters (including Turbo Elite®), Turbo-Booster® and Turbo Tandem™ SystemsLaser atherectomy and Paclitaxel-coated balloon angioplasty in treatment of instent lesions of femoropopliteal arteries |
| Drug eluting Ballon PTA | Active comparator | Device: Laser Atherectomy (Spectranetics CE marked peripheral laser atherectomy catheters (including Turbo Elite®), Turbo-Booster® and Turbo Tandem™ SystemsPaclitaxel-coated balloon angioplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must meet all of the following general inclusion criteria.
Key exclusion criteria (12 listed)
- The subject must not meet any of the following general exclusion criteria.
- 6. Has life expectancy of less than 12 months. 7. Is pregnant, of childbearing potential not taking adequate contraceptives, or nursing.
- 8. Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure.
- 9. Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure.
- 10. Is currently participating in an investigational drug or another device study that may clinically interfere with the study outcomes.
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 |
|---|---|---|
| Laser Atherectomy (Spectranetics CE marked peripheral laser atherectomy catheters (including Turbo Elite®), Turbo-Booster® and Turbo Tandem™ Systemscomparing the use of a Paclitaxel-eluting angioplasty balloon (PTX PTA) with initial photoablation to the use of PTX PTA alone in the treatment of instent lesions in femoropopliteal arteries | Device | Drug eluting Ballon PTA, Laser atherectomy and drug-coated balloon |
Primary outcome
Target Lesion Percent Stenosis
Time frame: at 1 Year
Target Lesion Percent Stenosis at 1 Year: Defined as the narrowest point of the target lesion divided by the estimated native vessel diameter at that location as determined by the angiographic core lab.
1 secondary outcome
Procedural Success
Time frame: at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
- 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.
Related trials for Restenosis
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Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Atherectomy (Spectranetics CE marked peripheral laser atherectomy catheters (including Turbo Elite®), Turbo-Booster® and Turbo Tandem™ Systems in people with Restenosis, run by Herz-Zentrums Bad Krozingen.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 21 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Target Lesion Percent Stenosis (time frame: at 1 Year). 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 NCT01298947, which also lists 1 linked publication.
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 Feb 2011.