Trial · NCT07359807
A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
NCT07359807, Phase 2, Phase 3, Not yet recruiting, Concept Medical Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries. Trials, record NCT07359807. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07359807
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
- NCT number
- NCT07359807
- Status
- Not yet recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 478 participants, estimated
- Lead sponsor
- Concept Medical Inc.
- Conditions
- Popliteal Artery Disease, Superficial Femoral Artery Disease
- Interventions
- Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter, Paclitaxel drug-coated balloon angioplasty
- First posted
- 2026-01-22
- Last updated
- 2026-04-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Vessel Patency Rate & Freedom from Post-Procedure Complications after One Year (12 months) | One year from index procedure | Measured by the absence of clinically driven target lesion revascularization (CD-TLR) due to symptoms and a drop of ABI of ≥ 20% or \> 0.15 when compared to post-procedure or restenosis with PSVR \> 2.4 evaluated by duplex ultrasound. Also, a composite of freedom from device and procedure-related death through 12-months post procedure, as well as freedom from target limb major amputation and clinically driven target vessel revascularization |
| Secondary | Long-term Safety and Efficacy of the Treated Vessel | Up to five years after index procedure | 1. Vesel patency at 6, 12, 24, and 48-month \& free of clinically-driven TLR at 1, 6, 12, 24, 36, 48, and 60-month 2. Sustained clinical improvement: an improvement shift in the Rutherford classification of at least one category in amputation and TVR-free surviving subjects at 12 months 3. Change in walking capacity assessment from pre-procedure to the respective follow-up visits 4. Duplex-defined binary restenosis (PSVR \> 2.4) of the target lesion post-procedure and at 6, 12, \& 24-months, or at any time of re-intervention 5. Hemodynamic improvement is defined as an increase in resting ankle brachial index (ABI) from pre-procedure to discharge, 6, 12, 24, and 48-months 6. Change in quality-of-life (QoL) assessment by VascuQol questionnaire and EQ5D-5L index questionnaire from pre-procedure through applicable follow-up visits 7. All-cause mortality at 1, 6, 12, 24, 36, 48, and 60-month 8. Target limb major amputation at 1, 6, 12, 24, 36, 48, and 60-month |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07359807
GET https://conductscience.org/api/trials/v1/NCT07359807/registered